BIOSYNEX STREPTATEST

Description of Event or Problem

A COMPLAINT WAS RECEIVED BY BIOSYNEX S.A. (BASED IN FRANCE) WHO IS A 3RD PARTY MANUFACTURER OF STREP A RAPID TEST STRIP KITS. THE TEST DEVICE CONTAINED IN BIOSYNEX'S KIT IS MANUFACTURED BY ABON BIOPHARM (HANGZHOU) CO., LTD. THIS MDR IS BEING SUBMITTED BY THE DEVICE PRODUCT MANUFACTURER ABON BIOPHARM (HANGZHOU) CO., LTD AS THE DEVICE IN THE TEST KIT IS SAME/SIMILAR TO STREP A PRODUCT CATALOG (IST-501D) THAT IS MARKETED IN THE US. ON THE (B)(6) 2022, A CUSTOMER REPORTED THE DEATH OF A 6-YEAR-OLD CHILD AND A FALSE NEGATIVE RESULT WHEN USING STREP A RAPID TEST STRIP (PART NUMBER: IST-501) LOT NUMBER STA2022007. THE PATIENT WAS SEEN BY AN ATTENDING PHYSICIAN ON (B)(6) 2022, WHO PERFORMED A STREP A TEST AND A NEGATIVE RESULT WAS OBTAINED. THE DOCTOR SENT THE CHILD HOME WITH A SUSPICION OF VIRAL INFECTION. THE NEXT DAY, (B)(6) 2022, THE CHILD'S MOTHER SENT AN EMAIL TO THE ATTENDING PHYSICIAN OUTLINING THAT THE CHILD WAS STILL UNWELL AND HAD A NUMBER OF LESIONS. THE ATTENDING PHYSICIAN RECOMMENDED THAT THEY GO TO THE EMERGENCY ROOM. THE CHILD DIED ON THE WAY TO (B)(6) UNIVERSITY HOSPITAL ON THE (B)(6) 2022 FOLLOWING STREPTOCOCCUS A MENINGITIS. ANSM (FRENCH NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS) WAS INFORMED OF THE DEATH OF THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION PROVIDED UNABLE TO IDENTIFY ANY MISUSE OR DEVIATION AGAINST THE PACKAGE INSERT. NO IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW.

Additional Manufacturer Narrative

ABON BIOPHARM ((B)(4)) CO., LTD (MANUFACTURER) INVESTIGATION RESULTS: A REVIEW OF BATCH HISTORY RECORD (B)(4) AND DEVIATION HISTORY CONFIRMED THERE WERE NO RELEVANT NON-CONFORMANCES OR DEVIATIONS FOR THIS LOT AND THE QUALITY CONTROL (QC) RELEASE DATA MET QC SPECIFICATION. RETAIN PRODUCT TESTING WAS PERFORMED ON LOT STA2022007. ALL RETAINED DEVICES WERE TESTED WITH QC POSITIVE SAMPLE AND RESULTS WERE READ AT 5 MINUTES. ALL RETAINED DEVICES SHOWED EXPECTED POSITIVE RESULTS USING POSITIVE SAMPLES. FALSE NEGATIVE RESULTS WERE NOT OBSERVED. AS PER THE IFU (INSTRUCTIONS FOR USE) FOR THIS PRODUCT A NEW SAMPLE MUST BE COLLECTED AND TESTED BY TRADITIONAL CULTURE METHODS IF A GROUP A STREPTOCOCCUS INFECTION IS SUSPECTED DESPITE A NEGATIVE RESULT. FROM THE INFORMATION PROVIDED BY THE CUSTOMER IT CANNOT BE CONFIRMED IF A NEW PATIENT SAMPLE WAS TESTED VIA A CULTURE METHOD. THE CUSTOMER REPORTED ISSUE WAS NOT REPLICATED. NO PRODUCT DEFICIENCY WAS IDENTIFIED DURING THIS INVESTIGATION. THIS COMPLAINT WILL BE TRACKED AND TRENDED. BELOW IS A LIST OF POTENTIAL CAUSES OF A FALSE NEGATIVE RESULT; THE BACTERIA WAS NO LONGER PRESENT IN THE TONSILS DURING SAMPLING, THE ENTRY POINT OF THE BACTERIA IS NON-ORAL, AN ANTIBIOTIC WAS TAKEN BEFORE THE TEST WAS CARRIED OUT, THE BACTERIUM PRESENT IS AT A RATE BELOW THE DETECTION THRESHOLD OF THE TEST, INSUFFICIENT QUALITY OF THE SAMPLE, AND/OR THE SWABBING HAD BEEN CARRIED OUT INCORRECTLY. THE TEST WAS PERFORMED INCORRECTLY; PROCEDURE NOT FOLLOWED, THE READING WAS INCORRECT, IN THE EVENT OF A FAINT VISIBLE TEST BAND, THE TEST AND/OR THE SWAB WAS DAMAGED IN THE EVENT OF INADEQUATE STORAGE A COMBINATION OF THESE POTENTIAL CAUSES CAN ALSO BE CONSIDERED. IN CONCLUSION, THE PRODUCT IFU STATES THAT A NEW SAMPLE MUST BE COLLECTED AND TESTED BY TRADITIONAL CULTURE METHODS IF A GROUP A STREPTOCOCCUS INFECTION IS SUSPECTED DESPITE A NEGATIVE RESULT. AS WITH ANY IN VITRO DIAGNOSIS, THE CLINICAL DIAGNOSIS SHOULD NOT BE BASED ON THE TEST RESULT ALONE BUT SHOULD BE MADE BY THE CLINICIAN AFTER ALL CLINICAL AND BIOLOGICAL ASSESSMENTS HAVE BEEN COMPLETED.

Additional Manufacturer Narrative

THIS INVESTIGATION IS ON-GOING AND AN ADDITIONAL SUPPLEMENTAL MDR WILL BE FILED WITH FURTHER UPDATES. CORRECTED PRODUCT CODE (D2): GTY. THIS MDR IS A SUPPLEMENTAL TO 3005641941-2022-00007.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED ON THE 11 JAN 2023 FROM BIOSYNEX S.A.(THIRD PARTY MANUFACTURER) IN RELATION TO LOT STA2022007. AN INDEPENDENT EVALUATION OF THIS LOT WAS COMPLETED BY THE NATIONAL REFERENCE CENTER FOR STREPTOCOCCI (CNR) AND BY THE DIRECTORATE OF CONTROLS (CTROL) OF ANSM. TESTING WAS COMPLETED USING THE STREP A STRAIN FOUND IN THIS CHILD WITH RESULTS CONFIRMING THAT THE STRAIN WAS DETECTED USING LOT STA2022007. THIS INVESTIGATION IS ON-GOING AND AN ADDITIONAL SUPPLEMENTAL MDR WILL BE FILED WITH FURTHER UPDATES. THIS MDR IS A SUPPLEMENTAL TO 3005641941-2022-00007.

Additional Manufacturer Narrative

MDR 3005641941-2022-00007 WAS INITIALLY FILED BASED ON A COMPLAINT RECEIVED FROM BIOSYNEX S.A., A MANUFACTURER BASED IN FRANCE, WHO PURCHASE THE PRODUCT FROM THE SUPPLIER (ABON BIOPHARM (HANGZHOU) CO., LTD), AND COMMERCIALIZE THE PRODUCT IN AN OWN-LABEL BASIS. THE POUCHED STRIPS CONTAINED IN THE BIOSYNEX STREPTATEST ARE MANUFACTURED BY ABON BIOPHARM, AND THEN SHIPPED TO BIOSYNEX S.A. FOR FURTHER PACKAGING INTO KIT AND INCLUSION OF THE BIOSYNEX S.A. INSTRUCTIONS FOR USE (IFU). ABON BIOPHARM FILED THE ABOVE MDR AS THE DEVICES IN THE BIOSYNEX STREPTATEST TEST KIT ARE SAME/SIMILAR TO THE STREP A RAPID TEST STRIP MARKETED IN THE US UNDER 510(K) K010582. INITIAL COMPLAINT FROM CUSTOMER WAS MADE TO BIOSYNEX VIA ANSM (THE FRENCH NATIONAL AGENCY FOR MEDICINES AND HEALTH PRODUCT SAFETY). BIOSYNEX HAVE NOT BEEN MADE AWARE OF THE CUSTOMER NAME AND ONLY RECEIVED LIMITED INFORMATION FROM ANSM. BIOSYNEX REQUESTED CUSTOMER DETAILS AND FURTHER INFORMATION FROM ANSM HOWEVER THIS DETAIL HAS NOT BEEN SHARED TO DATE. PLEASE SEE BELOW FOR A SUMMARY OF INVESTIGATION CONDUCTED AND CONCLUSION: RETAIN TESTING PRODUCT TESTING WAS PERFORMED ON LOT STA2022007; (B)(4) FROM THIS LOT OF RETAINED DEVICES WERE TESTED WITH QC POSITIVE SAMPLES ACCORDING TO PROCEDURE, AND RESULTS WERE READ AT 5 MINUTES PER THE IFU (INSTRUCTION FOR USE). ALL RETAINED DEVICES TESTED SHOWED EXPECTED POSITIVE RESULTS USING POSITIVE SAMPLES. FALSE NEGATIVE RESULTS WERE NOT OBSERVED AND NO PRODUCT DEFICIENCY IDENTIFIED AND THE ALLEGED FALSE NEGATIVE WAS NOT REPLICATED. MANUFACTURING BATCH RECORDS FOR LOT STA2022007 WERE REVIEWED AND CONFIRMED THERE WERE NO NON-CONFORMANCES OR MANUFACTURING DEVIATIONS FOR THIS LOT AND THE QUALITY CONTROL (QC) RELEASE DATA MET QC SPECIFICATION. A REVIEW OF THE INSTRUCTIONS FOR USE FOR BIOSYNEX STREPTATEST WAS CONDUCTED AND NOTED THAT THE IFU CONTAINS THE FOLLOWING INFORMATION IN RELATION TO NEGATIVE TEST RESULTS: - A NEW SAMPLE MUST BE COLLECTED AND TESTED BY TRADITIONAL CULTURE METHODS IF A GROUP A STREPTOCOCCUS INFECTION IS SUSPECTED DESPITE A NEGATIVE RESULT. - AS FOR ANY IN-VITRO DIAGNOSTIC, THE CLINICAL DIAGNOSIS SHOULD NOT BE BASED ON THE SOLE TEST RESULT BUT SHOULD BE MADE BY THE CLINICIAN AFTER ALL CLINICAL AND LABORATORY EVALUATIONS HAVE BEEN COMPLETED. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. DUE TO INSUFFICIENT INFORMATION BEING PROVIDED IT WAS NOT POSSIBLE TO CONFIRM IF THE IFU WAS ADHERED TO OR TO IDENTIFY IF THERE WAS ANY MISUSE OF DEVICE OR DEVIATION FROM THE PACKAGE INSERT. FROM THE INFORMATION THAT WAS PROVIDED BY THE CUSTOMER IT CANNOT BE CONFIRMED IF A NEW PATIENT SAMPLE WAS TESTED VIA A CULTURE METHOD. ANSM REQUESTED SAMPLES FROM LOT STA2022007 TO BE PROVIDED FOR EVALUATION. BIOSYNEX PROVIDED SAMPLES TO ANSM FOR EVALUATION AND RECEIVED FEEDBACK FROM ANSM THAT THE BATCH WAS FOUND TO CONFORM AND REACTED AS INTENDED. THE RISK MANAGEMENT REPORT (B)(4) WAS REVIEWED AND FALSE NEGATIVE RESULTS ASSESSED FOR THIS PRODUCT IST-501 SHOWED NO NEW HAZARD WAS IDENTIFIED. THE COMPLAINT HISTORY DATA FOR PRODUCT STREP A RAPID TEST STRIP HAS BEEN REVIEWED. IN THE PREVIOUS TWO YEARS ((B)(6) 2021 TO (B)(6) 2022), 30 FALSE NEGATIVE COMPLAINTS HAVE BEEN RECEIVED, WITH THE EXCEPTION OF THIS COMPLAINT, THERE WAS ONE OTHER COMPLAINT WHICH MENTIONED DEATH OR SERIOUS INJURY ( MDR 3005641941-2023-00001). COMPLAINTS WILL CONTINUE TO BE MONITORED AND TRACKED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN MORE INFORMATION, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. BASED ON ABOVE INFORMATION THERE HAS BEEN NO DEVICE DEFICIENCY IDENTIFIED AND THE INVESTIGATION IS DEEMED COMPLETE. SHOULD ANY FURTHER FEEDBACK BE RECEIVED FROM ANSM, ABON BIOPHARM (HANGZHOU) CO. LTD WILL FILE A SUPPLEMENTAL REPORT WITH THE FINDINGS.