BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGG

    MDR report key: 8634714 · Received May 22, 2019

    Report

    Report Number
    8020790-2019-00029
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Report Date
    August 28, 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

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR OUT OF RANGE LOW (OORL) RESULTS FOR A QUALITY CONTROL SAMPLE, WHEN TESTED ON VIDAS® LYME IGG BATCH 1006940510/ 191107-0. THE CUSTOMER SUBMITTED THEIR INTERNAL QUALITY CONTROL ACCURUN SAMPLE FOR THE INVESTIGATION. BIOMÉRIEUX PERFORMED INVESTIGATION TESTING WHICH INCLUDED TESTING SEVEN INTERNAL SERA WITH SEVEN LOTS OF VIDAS LYME IGG, INCLUDING LOT 1006940510/ 191107-0. THE TESTS INCLUDED ONE NEGATIVE TEST, THREE POSITIVE TESTS WITH WEAK INDEXES, AND THREE POSITIVE TESTS WITH HIGH INDEXES. ALL THE RESULTS WERE WITHIN SPECIFICATIONS. THE INTERNAL QUALITY CONTROL SAMPLE ACCURUN WAS ALSO TESTED ON FOUR DIFFERENT BATCHES INCLUDING THE TWO BATCHES USED BY CUSTOMERS. ALL THE RESULTS WERE POSITIVE WITH HIGH INDEXES FAR FROM THE CUT-OFF. THE INVESTIGATION REPRODUCED THE BATCH TO BATCH VARIABILITY WHEN TESTING THE ACCURUN SAMPLE, THOUGH THE INDEXES WERE HIGH (POSITIVE INTERPRETATION) WITH LEVELS FAR FROM THE CUT-OFF FOR VIDAS LYME IGG AND WERE WITHIN THE PRODUCT SPECIFICATIONS. VIDAS LYME IGG BATCH 1006940510/ 191107-0 PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED OUT OF RANGE LOW (OORL) RESULTS FOR A QUALITY CONTROL STRAIN IN ASSOCIATION WITH A NEW LOT OF VIDAS® LYME IGG (LOT 1006940510). THE CUSTOMER REPORTED THAT THEIR INGEN CONTROL LOT (10311545) USED BETWEEN (B)(6) 2018 AND (B)(6) 2018, FOR TWO BATCHES OF LYME IGG, HAD A TARGET OF 4.73 WITH THE CV AT 10% (RANGES 2SD 3.78-5.68). VIDAS LOT 1006940510, VALUES WERE 3.26, 3.31, 3.4, 3.36, 3.38 AND 3.32. THE CUSTOMER STATED THERE WAS NO CHANGE IN INTERPRETATION. THE EVENT INVOLVED A QUALITY CONTROL STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425637 VIDAS® LYME IGG VIDAS® LYME IGG LGD BIOMERIEUX SA 1006940510

    Patients

    Seq Age Sex Outcome Treatment
    1