BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM 30 TESTS

    MDR report key: 11703869 · Received April 21, 2021

    Report

    Report Number
    8020790-2021-00110
    Event Type
    Malfunction
    Date Received
    April 21, 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
    US
    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 ; 30205-01). 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. A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING INVALID CALIBRATION RESULTS IN ASSOCIATION WITH THE VIDAS® CMV IGM 30 TESTS (REF. 30205, LOT 1008433580). THE CUSTOMER ATTEMPTED TO CALIBRATE LOT 1008433580 PRIOR TO USE ON CLINICAL SAMPLES. INVALID CALIBRATION RESULTS WERE OBTAINED; THE S1 VALUE WAS OUT OF RANGE DUE TO THE RFV BEING TOO HIGH. THE CUSTOMER REPORTED THAT THEY DID NOT HAVE OTHER VIDAS® CMV IGM 30 LOTS AVAILABLE, AND THEREFORE THE FAILED CALIBRATIONS LED TO A DELAY >24 HOURS IN REPORTING PATIENT RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE INVALID CALIBRATION RESULT OR DELAY LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE VIDAS® CMV IGM PACKAGE INSERT ¿CALIBRATION¿ SECTION STATES, "CALIBRATION USING THE STANDARD PROVIDED IN THE KIT MUST BE PERFORMED EACH TIME A NEW LOT OF REAGENTS IS OPENED, AFTER THE MASTER LOT DATA HAVE BEEN ENTERED." THE VIDAS® CMV IGM 30 TESTS (REF 30205, BATCH 1008433580) FAILED CALIBRATION; THEREFORE NO RESULTS WERE EXPECTED. IF THE CALIBRATION IS INVALID THE USER HAS AN ALERT ON THE EQUIPMENT THAT THEY CANNOT REPORT PATIENT RESULTS. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION. 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. NOTE: THIS SITUATION DOES NOT PRESENT A RISK OF A FALSE RESULT. IF THE CALIBRATION IS INVALID THE USER HAS AN ALERT ON THE EQUIPMENT THAT HE CANNOT GIVE PATIENT RESULTS. ADDITIONALLY, THE VIDAS® CMV IGM PACKAGE INSERT ¿CALIBRATION¿ SECTION STATES, "CALIBRATION USING THE STANDARD PROVIDED IN THE KIT MUST BE PERFORMED EACH TIME A NEW LOT OF REAGENTS IS OPENED, AFTER THE MASTER LOT DATA HAVE BEEN ENTERED." THE RISK PRESENTED IS THE POTENTIAL FOR A DELAYED RESULT. THIS SITUATION DOES NOT PRESENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO PUBLIC HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598483 VIDAS® CMV IGM 30 TESTS VIDAS® CMV IGM 30 TESTS LKQ BIOMERIEUX SA 1008433580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown