VIDAS® B·R·A·H·M·S PCT¿

Description of Event or Problem

INTENDED USE VIDAS® B·R·A·H·M·S PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B¿R¿A¿H¿M¿S PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT¿ ALSO AIDS IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS (LRTI) (INCLUDING COMMUNITY ACQUIRED PNEUMONIA, EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ACUTE BRONCHITIS) SEEN DURING MEDICAL CONSULTATIONS, INCLUDING AT THE EMERGENCY DEPARTMENT. IN CERTAIN SITUATIONS (NEWBORNS, POLYTRAUMA, BURNS, MAJOR SURGERY, PROLONGED OR SEVERE CARDIOGENIC SHOCK, ETC.) PCT ELEVATION MAY BE INDEPENDENT OF ANY INFECTIOUS AGGRESSION. THE RETURN TO NORMAL VALUES IS USUALLY RAPID. DESCRIPTION OF THE ISSUE ON 18-SEP-2024, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POTENTIAL OVERESTIMATED PATIENT RESULT WHEN USING VIDAS® B·R·A·H·M·S PCT¿ REFERENCE 30450 LOT 1010591060 (EXPIRY 31-AUG-2025). THE SERUM CAME FROM A PATIENT MALE OF 65 YEARS OLD WITH THE FOLLOWING CLINICAL STATUS: SYMPTOMS : HYPOVOLEMIA / DEHYDRATION / DIARRHEA / RENAL FAILURE LEADING TO ACIDOSIS CLINICAL HISTORY : SUBTOTAL COLECTOMY WITH ANASTOMOSIS / CHOLECYSTECTOMY / STAGE 3 RENAL FAILURE (IN 2020) / HYPOTHYROIDISM / DIABETES / ADRENAL INSUFFICIENCY / COPD / HYPERTENSION / ISCHEMIC HEART DISEASE (SEQUELAE OF INFARCTION) / INTESTINAL OCCLUSION (SEPTIC SHOCK) / PSYCHIATRIC ILLNESS (DEPRESSION) TREATMENTS : ALDACTONE / BISOPROLOLE / CARDEGIC / LEVOTHYROX / HYDROCORTISONE / SERESTA / PAROXETINE / CYAMEMAZINE / ZOPICLONE. THE PATIENT WAS IN INTENSIVE CARE WHEN SAMPLE WAS TAKEN. THE CUSTOMER OBTAINED THE FOLLOWING RESULT: 402 NG/ML WHILE THE PATIENT DID NOT SHOW ANY PROOF OF SEPSIS. AT THIS TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH OR DELAY IN RENDERING THE RESULT. THE PRODUCT, VIDAS® B·R·A·H·M·S PCT¿ REFERENCE 30450, IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, A SIMILAR PRODUCT, VIDAS® B·R·A·H·M·S PCT¿ REFERENCE (B)(4) IS SOLD IN THE UNITED STATES. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING POTENTIAL OVERESTIMATED PATIENT RESULT WHEN TESTING ONE PATIENT SAMPLE WITH VIDAS® B·R·A·H·M·S PCT¿ REFERENCE 30450 LOT 1010591060 (EXPIRY 31-AUG-2025). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: 1. DEVICE HISTORY RECORDS THERE IS NEITHER CAPA, NON-CONFORMITY NOR QUALITY EVENT LINKED TO THIS ISSUE RECORDED ON VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450, LOT 1010591060). 2. COMPLAINT ANALYSIS AT THE DATE OF INVESTIGATION, NO OTHER COMPLAINTS WERE RECORDED FOR POTENTIAL OVERESTIMATED PATIENT RESULT ON VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450, LOT 1010591060). 3. ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY 3.1. MATERIAL PROVIDED BY THE CUSTOMER TWO (2) SAMPLES WITH THE FOLLOWING IDENTIFICATION WERE PROVIDED BY THE CUSTOMER: (B)(6) THE PRESENCE OF VISIBLE CLOTS OF FIBRIN WAS NOTED. 3.2 CONTROL CHART ANALYSIS THIS ANALYSIS WAS CARRIED OUT: ON FOUR (4) INTERNAL SAMPLES WITH A RESPECTIVE TARGET AT 30.7 / 91.1 / 121 AND 154 NG/ML. ON SEVEN (7) BATCHES OF VIDAS® PCT (REF.30450) INCLUDING THE LOT 1010591060 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS. NO TREND WAS OBSERVED ON THE LOT 1010591060 COMPARED TO THE OTHER LOTS. 3.3 TESTS PERFORMED USING INTERNAL SAMPLES THE COMPLAINTS LABORATORY TESTED TWO (2) INTERNAL SAMPLES WITH A NEGATIVE INTERPRETATION (TARGET AT 30.7 AND 154 NG/ML) ON THE RETAIN KIT OF VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450, LOT 1010591060). BOTH SAMPLES GAVE A RESULT WITHIN ACCEPTANCE CRITERIA AND SHOWED NO SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCH RELEASE. 3.4 TESTS PERFORMED ON SAMPLES FROM THE CUSTOMER THE COMPLAINTS LABORATORY TESTED THE TWO (2) SAMPLES PROVIDED BY THE CUSTOMER ON THE RETAIN KIT OF VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450, LOT 1010591060). THE SAMPLES GAVE SIMILAR RESULTS AS THE ONES OBSERVED BY THE CUSTOMER AND THE RESULTS AFTER DILUTION 1:4 IN SERUM FREE ARE CONSISTENT WITH THE ONES OBSERVED ON THE UNDILUTED SAMPLES. THE DILUTION TESTING DID NOT HIGHLIGHT ANY INTERFERENCE. 3.5 TEST PERFORMED IN AN EXTERNAL LABORATORY THE COMPLAINTS LABORATORY SENT THE TWO (2) SAMPLES PROVIDED BY THE CUSTOMER TO AN EXTERNAL LABORATORY. THE RESULTS OBTAINED USING CMIA - ALINITY B.R.A.H.M.S PCT METHOD IS IN ACCORDANCE WITH THE ONES OBSERVED ON VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450, LOT 1010591060), NAMELY A PROCALCITONIN CONCENTRATION > 100 G/L (> 100 NG/ML) FOR THE FIRST SAMPLE AND A PROCALCITONIN CONCENTRATION OF 31.25 G/L (31.25 NG/ML) FOR THE SECOND ONE. 4. CONCLUSION A HIGH LEVEL OF PROCALCITONIN WAS CONFIRMED WITH BOTH METHODS (VIDAS® B·R·A·H·M·S PCT¿ AND CMIA - ALINITY B.R.A.H.M.S PCT METHOD). THUS, IT SEEMS THAT THE SAMPLES HAVE A HIGH CONCENTRATION OF PROCALCITONIN PROBABLY IN RELATION WITH THE VERY COMPLEX CLINICAL CONTEXT OF THIS PATIENT. ADDITIONALLY, AS MENTIONED IN THE PACKAGE INSERT OF VIDAS® B·R·A·H·M·S PCT¿ (REF.30450): ¿IN CERTAIN SITUATIONS (NEWBORNS, POLYTRAUMA, BURNS, MAJOR SURGERY, PROLONGED OR SEVERE CARDIOGENIC SHOCK, ETC.) PCT ELEVATION MAY BE INDEPENDENT OF ANY INFECTIOUS AGGRESSION. THE RETURN TO NORMAL VALUES IS USUALLY RAPID. VIRAL INFECTIONS, ALLERGIES, AUTOIMMUNE DISEASES AND GRAFT REJECTION DO NOT LEAD TO A SIGNIFICANT INCREASE IN PCT. A LOCALIZED BACTERIAL INFECTION CAN LEAD TO A MODERATE INCREASE IN PCT LEVELS.¿ ACCORDING TO THE ABOVE DATA, THE PERFORMANCE OF THE VIDAS® B·R·A·H·M·S PCT¿ (REF. 30450, LOT 1010591060) IS CONFORM TO THE EXPECTED SPECIFICATIONS.