BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM 30 TESTS

    MDR report key: 11983242 · Received June 11, 2021

    Report

    Report Number
    8020790-2021-00135
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Report Date
    October 6, 2022
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Removal / Correction Number
    FSCA 5109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMÉRIEUX RECEIVED SEVERAL COMPLAINTS ABOUT CALIBRATION ISSUE (THE CALIBRATOR VALUES ARE OUT OF RANGE TOO HIGH) OBSERVED ON VIDAS® CMV IGM (REF 30205 ; (B)(6) ). THIS INVESTIGATION HAS BEEN MANAGED BY A MULTIDISCIPLINARY TEAM INVOLVING SEVERAL DEPARTMENTS (MANUFACTURING SITE, R&D AND GLOBAL CUSTOMER SERVICE) WITH THE FOLLOWING RESULTS. 1. INVESTIGATION. A. BATCH HISTORY RECORDS. THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR THE CONCERNED VIDAS® CMV IGM LOTS DIDN¿T SHOW ANY ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. B. INVESTIGATION DETAILS. - INVESTIGATIONS PERFORMED ON PRE-ANALYTICAL STEPS, INSTRUMENT, STORAGE AND TRANSPORTATION OF THE KITS DO NOT SHOW ANY ANOMALY THAT COULD EXPLAIN THE ISSUE. INVALID CALIBRATIONS WERE NOT CONFIRMED ON EITHER CUSTOMER¿S KITS NOR ON RETAINED KITS. THE RFV VALUES OBTAINED DURING THE INVESTIGATION WERE NEAR TO THE HIGHER LIMIT OF THE RANGE WITHOUT NON-CONFORMING RESULTS. A DESIGN OF EXPERIMENTS (DOE) WAS DONE WITH A FOCUS ON THE CALIBRATOR S1 TO TRY TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. HOWEVER, IT DIDN¿T LEAD TO THE ROOT CAUSE IDENTIFICATION. THE INVESTIGATION CONFIRMED THAT THE CALIBRATOR¿S VALUE INCREASES DURING THE FIRST FEW DAYS AFTER PRODUCTION. THE ISSUE SEEMS TO BE LINKED TO THE NEW BIOLOGICAL STANDARD S1 FORMULATION (HUMAN FREE SERA) IMPLEMENTED SINCE APRIL 2019. ADDITIONAL STABILIZATION TIME OF THE BULK CONJUGATE USED IN STRIPS HAS BEEN IMPLEMENTED IN ORDER TO BALANCE EVOLUTION OF NEW S1 FORMULATION. THE STABILIZATION ACTION BEFORE RELEASE ALLOWED TO LIMIT THE CALIBRATION ISSUE ON THE FIELD AND TO RETURN TO A NORMAL TREND FOR THIS ISSUE TO DATE.

    Description of Event or Problem · 0

    NOTE: REFERENCE 30205 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30205-01. ON (B)(6) 2021, A CUSTOMER FROM (B)(6) REPORTED TO BIOMERIEUX THAT THEY OBSERVED INVALID CALIBRATION LEADING TO DELAYED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS® (B)(6) IGM 30 TESTS (REF. 30205, LOT 1008182270, EXPIRY DATE = 26-MAY-2021). THE CUSTOMER FIRST USED COBAS TEST (FROM ROCHE) BUT THE RESULT FOR (B)(6) IGM WAS NOT CLEAR. THEREFORE, THE CUSTOMER PROCEEDED TO CONFIRMATORY TESTING USING VIDAS (B)(6) IGM 30 TESTS KIT ON MINIVIDAS DEVICE BUT THE CALIBRATION WAS INVALID FOR ALL SAMPLES. THERE WAS NO POSSIBILITY TO ORDER A NEW BATCH OF VIDAS (B)(6) IGM 30 TESTS OR TO SEND THE SAMPLES TO ANOTHER LABORATORY SINCE THE ONE THEY TRIED HAD THE SAME ISSUE (LABORATORY IN (B)(6)). CONSEQUENTLY, THE PATIENTS HAD TO WAIT TWO WEEKS FOR THEIR RESULTS ON (B)(6) IGM. AT THE TIME OF REPORTING, THERE WAS NO EVIDENCE OF PATIENT HARM. THE CUSTOMER REPORTED A SIMILAR ISSUE WITH ANOTHER BATCH OF VIDAS (B)(6) IGM 30 TESTS: - BATCH 1008363970 REPORTED UNDER (B)(4). BATCH 1008182270 INVOLVED IN THIS COMPLAINT IS INCLUDED IN THE SCOPE OF THE FSCA #5109 ISSUED ON 16-MAR-2021. THE CUSTOMER HAD PREVIOUSLY RECEIVED ONE BOX OF THE IMPACTED LOT. THEY ATTEMPTED TO USE IT AND TRIED A CALIBRATION BEFORE RECEIVING THE LETTER FROM BIOMÉRIEUX. AFTER RECEIVING THE LETTER, THEY DESTROYED THE KIT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. ON 17 MAR 2021 BIOMERIEUX SENT RECALL 8020790-03/17/21-001 (FSCA 5109) TO FDA FOR THE ISSUE OF INVALID CALIBRATIONS FOR FOUR (4) NON-US LOTS OF REFERENCE 30205 AND TWO (2) US LOTS OF REFERENCE 30205-01. THE FOUR (4) NON-US LOTS HAVE SEEN AN INCREASE IN CUSTOMER COMPLAINTS FOR CALIBRATION FAILURES. AS THE ROOT CAUSE OF THE INVALID CALIBRATION IS CURRENTLY UNDER INVESTIGATION, IT HAS BEEN DECIDED THAT ALL SIX LOTS, INCLUDING THE LOTS SOLD IN THE US, WILL BE ACTED UPON AS PRECAUTIONARY MEASURE. THE INVESTIGATION INTO THE ROOT CAUSE ACTIVELY CONTINUES. TO DATE, INTERNAL TESTING HAS NOT REPLICATED THE CALIBRATION FAILURE ON ANY OF THESE LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878189 VIDAS® CMV IGM 30 TESTS VIDAS® CMV IGM 30 TESTS LKQ BIOMERIEUX SA 1008182270

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown