BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CK MB

    MDR report key: 8286105 · Received January 29, 2019

    Report

    Report Number
    8020790-2019-00007
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Report Date
    March 12, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JHX
    PMA / PMN Number
    K962549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN SOUTH AFRICA REPORTING A FALSELY ELEVATED RESULT FOR AN EXTERNAL QUALITY CONTROL (EQA SAMPLE "LANCET - STANDTON" CYCLE 8 NUMBER 1) SAMPLE IN ASSOCIATION WITH THE VIDAS® CK MB ASSAY (LOT 1006158480). THE CUSTOMER DID NOT SUBMIT THE SAMPLE FOR EVALUATION. NO SAMPLE ANALYSIS COULD BE PERFORMED. A REVIEW OF QUALITY RECORDS CONFIRMED THERE WAS NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES, AND NO CAPA, OR NON-CONFORMITY RECORDED FOR VIDAS CKMB ASSAY (LOT 1006158480). CONTROL CHART ANALYSIS WAS PERFORMED ON FIVE INTERNAL SAMPLES (TARGET: 44.9-16.1-40.1-74.2-109 NG/ML) ON FIVE DIFFERENT BATCHES OF VIDAS CKMB REF 30421 INCLUDING THE CUSTOMER'S (LOT 1006158480/181111-0) THE ANALYSIS SHOWED THAT VIDAS CKMB REF 30421 LOT 1006158480/181111-0 IS IN THE TREND OF OTHER BATCHES. COMPLAINT TRENDING ANALYSIS SHOWED NO OTHER COMPLAINT FOR VIDAS CKMB ASSAY (LOT 1006158480). IN CONCLUSION, THE VIDAS CKMB REF 30421 LOT 1006158480/181111-0 IS WITHIN THE EXPECTED PERFORMANCES. WITHOUT THE CUSTOMER'S RETURN SAMPLE, AND AS VIDAS CKMB LOT 1006158480/181111-0 HAS EXPIRED, IT IS NOT POSSIBLE TO PURSUE FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSELY ELEVATED RESULT FOR AN EXTERNAL QUALITY CONTROL (EQA) SAMPLE IN ASSOCIATION WITH THE VIDAS® CK MB ASSAY (LOT: 1006158480). THE CUSTOMER REPORTED THAT FOR CYCLE 8, SAMPLE 1 THE RESULT WAS TOO HIGH. THE CUSTOMER STATED THAT EQA WAS PERFORMED ONCE PER MONTH AND THE ASSAY WAS REPEATED WITH SIMILAR RESULTS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A QUALITY CONTROL SAMPLE. THE CUSTOMER STATED OTHER TESTING WAS THEN PERFORMED ON DIFFERENT ANALYZERS AT DIFFERENT LABS. THE BIOMÉRIEUX LOCAL APPLICATION SPECIALIST REQUESTED SAMPLES FROM TWO DIFFERENT LABS TO CROSS CHECK BUT HIGH RESULTS WERE OBTAINED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78901 VIDAS® CK MB VIDAS® CK MB JHX BIOMERIEUX SA 1006158480

    Patients

    Seq Age Sex Outcome Treatment
    1