KIT FLU VERITOR SYSTEM 30 TEST JAPAN
Received Mar 1, 2022 · Event occurred Feb 2, 2022
Report 3006948883-2022-00046 · MDR key 13641122
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Catalog number
256052
Lot number
UNKNOWN
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE KIT FLU A+B 30 TEST PHYSICIAN VERITOR CATALOG NUMBER 256045 WHICH HAS 510K NUMBER K112277.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A FALSE POSITIVE. ACCORDING TO THE CUSTOMER'S REPORT, THE RESULT APPEARS TO BE POSITIVE WITH A SAMPLE WHICH IS SUPPOSEDLY NEGATIVE."
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A FALSE POSITIVE. ACCORDING TO THE CUSTOMER'S REPORT, THE RESULT APPEARS TO BE POSITIVE WITH A SAMPLE WHICH IS SUPPOSEDLY NEGATIVE."
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN (MATERIAL # 256052), BATCH NUMBER UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. A PHOTOGRAPH WAS RETURNED AND SHOWED TWO KIT FLU VERITOR SYSTEM 30 TEST JAPAN TEST DEVICE WITH RESULTS AND UNABLE TO CONFIRM OF FALSE POSITIVE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.