BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGG

    MDR report key: 8644131 · Received May 27, 2019

    Report

    Report Number
    8020790-2019-00030
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    April 30, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K101946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS COMPLETED IN RESPONSE TO A CUSTOMER IN FRANCE REPORTING FALSE UNDERESTIMATED RESULTS (NEGATIVE) FOR ONE PATIENT SAMPLE (SAMPLE (B)(6)) WITH VIDAS® LYME IGG 60 TESTS (LOT 1006940510). THE INVESTIGATION INCLUDED TESTING OF INTERNAL BIOMÉRIEUX SAMPLES (BOTH POSITIVE AND NEGATIVE), FOUR (4) SAMPLES SUBMITTED BY THE CUSTOMER, AND AN INTERNAL QUALITY CONTROL SAMPLE (POSITIVE). ALL SAMPLES WERE TESTED USING THE TWO (2) LOTS OF VIDAS® LYME IGG 60 TESTS USED BY THE CUSTOMER AS WELL AS OTHER PRODUCTION LOTS NOT USED BY THE CUSTOMER. TESTING THE INTERNAL SAMPLES THAT WERE KNOWN TO BE POSITIVE OR NEGATIVE PRODUCED THE EXPECTED RESULTS, RESPECTIVELY, FOR ALL LOTS USED FOR INVESTIGATIONAL TESTING. RESULTS FOR THE POSITIVE INTERNAL QUALITY CONTROL SAMPLE WERE POSITIVE FOR ALL LOTS USED FOR INVESTIGATIONAL TESTING. ALL RESULTS FROM TESTING THE SAMPLES SUBMITTED BY THE CUSTOMER PRODUCED POSITIVE RESULTS. INVESTIGATIONAL TESTING WITH THE VIDAS LYME IGG ASSAY DID NOT REPRODUCE THE NEGATIVE RESULTS OBSERVED BY THE CUSTOMER. THE SAMPLE (B)(6) WAS NEGATIVE USING IMMUNOBLOT-MIKROGEN IGG AND IGM (BIOMNIS RESULTS) AND ALSO WITH THE LYMECHECK® OPTIMA IGG TEST KIT (COMPLAINTS LABORATORY TESTING RESULT). ACCORDING TO THE DATA MENTIONED ABOVE, THE POSITIVE RESULTS (ALL CLOSE TO THE CUT-OFF) OBSERVED ON SAMPLE (B)(6) ARE LIKELY ATTRIBUTEDTO NONSPECIFIC BINDING WITH VIDAS LYME IGG ASSAY. THE ANALYSIS OF VIDAS LYME IGG BATCH 1006940510/ 191107-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL, AND PACKAGING PROCESSES.

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE OF THIS REPORT, WAS CORRECTED FROM (B)(6) 2019 TO (B)(6) 2019.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE UNDERESTIMATED RESULTS WITH VIDAS® LYME IGG 60 TESTS (LOT1006940510). THE CUSTOMER FIRST REPORTED UNDERESTIMATED RESULTS REGARDING INTERNAL QUALITY CONTROL TESTS ON (B)(6) 2019. ON (B)(6) 2019, THE CUSTOMER TESTED SERA SAMPLES FROM THREE (3) PATIENTS (FROM THE SERUM BANK OF THE LABORATORY) ON TWO DIFFERENT LOTS INCLUDING LOT 1006940510, RESULTING IN A FALSE NEGATIVE RESULT WITH A FEMALE PATIENT SAMPLE. THE RESULTS WERE THE FOLLOWING: PATIENT 1: (MALE): VIDAS / LOT 1006756630: LYME IGG VALUE = 0.57 (POSITIVE). VIDAS / LOT 1006940510: LYME IGG VALUE = 0.42 (POSITIVE). PATIENT 2: (MALE): VIDAS / LOT 1006756630: LYME IGG VALUE = 0.55 (POSITIVE). VIDAS / LOT 1006940510: LYME IGG VALUE = 0.46 (POSITIVE). PATIENT 3: (FEMALE): VIDAS / LOT 1006756630: LYME IGG VALUE = 0.23 (POSITIVE). VIDAS / LOT 1006940510: LYME IGG VALUE = 0.17 (NEGATIVE). THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437048 VIDAS® LYME IGG VIDAS® LYME IGG LGD BIOMERIEUX SA 1006940510

    Patients

    Seq Age Sex Outcome Treatment
    1