BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® BRAHMS PROCALCITONIN

    MDR report key: 8133944 · Received December 5, 2018

    Report

    Report Number
    3002769706-2018-00250
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    September 4, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PRI
    PMA / PMN Number
    K162827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING A REPORT FROM A CUSTOMER IN MALAYSIA REGARDING A FALSELY UNDERESTIMATED RESULT IN ASSOCIATION WITH THE VIDAS® BRAHMS PROCALCITONIN (PCT) ASSAY. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED; THERE WAS NO RETURN KIT OR SPECIMEN AVAILABLE FROM THE CUSTOMER. EVALUATION OF THE MANUFACTURING QC BATCH RECORDS INDICATED THE FOLLOWING: NO CAPA NOR NON-CONFORMITY LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON VIDAS B·R·A·H·M·S PCT¿ PARAMETER (REF. 30450). ANALYSIS OF THE BATCH HISTORY RECORDS: NO ANOMALY RECORDED DURING THE MANUFACTURING AND CONTROL PROCESSES; CONTROL CHARTS ANALYSIS: ALL RESULTS ARE CONFORM TO EXPECTED SPECIFICATION AND WELL TARGETED ON THIS BATCH; NO OTHER SIMILAR COMPLAINT ON THIS BATCH NUMBER 1006397040/190321-0. TESTS PERFORMED: WITHOUT RETURN SAMPLE AVAILABLE, TESTING OF THE INTERNAL SAMPLES ON THE RETAINED (IN HOUSE) KIT WAS PERFORMED. ALL TESTS CONFORMED TO EXPECTED SPECIFICATIONS; ON ALL THE SPR® OBSERVED ON THE BATCH 1006397040/190321-0 , NO ANOMALY WAS DETECTED; ON ALL TEST VARIATIONS PERFORMED IN ORDER TO TRY TO REPRODUCE THE CUSTOMER ANOMALY, ONLY A BADLY POSITIONED STRIP COULD GIVE A VERY LOW BACKGROUND NOISE READING AND LOWER RESULT THAN EXPECTED. REVIEW OF INSTRUCTIONS FOR USE [MINI VIDAS USER MANUAL (161150-637-B)]: (5-23): "LOADING REAGENT STRIPS AND SOLID PHASE RECEPTACLES (SPR®). CAUTION: MAKE SURE THE STRIP IS FIRMLY PLACED BY SLIDING IT ALL THE WAY UNTIL YOU FEEL THE STRIP LOCK INTO THE SECTION CHANNEL. CAUTION: WHEN PLACING THE SPR® IN THE SPR® BLOCK POSITION, DO NOT APPLY PRESSURE TO THE BLOCK POSITION AS THIS MAY CAUSE THE SPR® TO BE EJECTED." (5-25): "IMPORTANT: WHEN UNLOADING THE REAGENT STRIPS AND SOLID PHASE RECEPTACLES (SPR®), CAREFULLY READ THE PRECAUTIONS DESCRIBED IN PRECAUTIONS FOR USE OF REAGENTS ON PAGE 2-11, SECTION «AT THE END OF THE RUN». (2-11): DO NOT USE VISIBLY DETERIORATED STRIPS (DAMAGED FOIL OR PLASTIC) OR IF REAGENTS ARE LEAKING, AS THIS COULD AFFECT THE ACCURACY OF TEST RESULTS." THE INVESTIGATION CONCLUDED THAT VIDAS BRAHMS PROCALCITONIN REF 30450, BATCH NUMBER 1006397040/190321-0 (EXP. 21 MAR 2019) IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSELY UNDERESTIMATED RESULT IN ASSOCIATION WITH THE VIDAS® BRAHMS PROCALCITONIN ASSAY. THE CUSTOMER STATED THE INITIAL TEST DID NOT GIVE THE CORRECT RESULT BASED ON THE BACKGROUND READING, RFV, AND PATIENT CONDITION, AND THAT THE REPEAT TEST WAS CONSISTENT WITH THE PATIENT'S CRITICAL CONDITION WITH SEPSIS. THE PATIENT HAD A POSITIVE BLOOD CULTURE ON (B)(6) 2018, AND PCT WAS RUN ON (B)(6) 2018. THE CUSTOMER MENTIONED THEY FOUND A STUCK SOLID PHASE RECEPTACLES (SPR®) AT THE END OF THE INITIAL RUN. POSITION A1 - INITIAL TEST: BACKGROUND READING : 23, SAMPLE RFV: -9, RESULT (NG/ML): < 0.05. POSITION B1 - REPEAT TEST: BACKGROUND READING : 169, SAMPLE RFV: 763, RESULT (NG/ML): 15.12. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO PATIENT TREATMENT AS THE REPEAT RESULT WHICH WAS CONSISTENT WITH THE BLOOD CULTURE POSITIVE RESULT, WAS REPORTED TO THE PHYSICIAN. IT WAS REPORTED THAT THE PATIENT CONDITION IMPROVED AND THEY WERE DISCHARGED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974282 VIDAS® BRAHMS PROCALCITONIN VIDAS® BRAHMS PCT PRI BIOMERIEUX SA 1006397040

    Patients

    Seq Age Sex Outcome Treatment
    1