BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGG ASSAY

    MDR report key: 8855419 · Received August 2, 2019

    Report

    Report Number
    8020790-2019-00039
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFZ
    PMA / PMN Number
    K920661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR NON-REPRODUCIBLE RESULTS WITH VIDAS® CMV IGG (LOT 1007040560/ 191112-0). THE CUSTOMER SUBMITTED THE SAMPLE (DUFJO) (B)(6) FOR EVALUATION: A REVIEW OF QUALITY RECORDS CONFIRMED THERE WAS NO CAPA OR NONCONFORMITY RECORDED ON VIDAS CMV IGG LINKED TO CUSTOMER'S ISSUE. VIDAS CMV IGG REF 30204 LOT 1007040560/ 191112-0 HAD NO ANOMALY DURING THE MANUFACTURING , CONTROL AND PACKAGING PROCESSES. ONE OTHER SIMILAR COMPLAINT WITH VIDAS CMV IGG, LOT 1007040560/ 191112-0. CONTROL CHARTS ANALYSIS WAS PERFORMED FOR FOUR INTERNAL SERA (TWO NEGATIVES AND TWO LOW POSITIVES) ON SEVEN DIFFERENT BATCHES OF VIDAS CMV IGG REF. 30204, INCLUDING THE CUSTOMER'S LOT 1007040560/ 191112-0. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS, AND LOT 007040560 WAS IN THE TREND OF THE OTHER LOTS. TESTING WAS PERFORMED WITH A VIDAS CMV IGG LOT 1007040560/ 191112-0 RETAINED KIT AND FOUR INTERNAL SERA (TWO NEGATIVES AND TWO LOW POSITIVES) . ALL INTERNAL SAMPLE RESULTS WERE WITHIN SPECIFICATIONS AND SIMILAR TO RESULTS OBTAINED BEFORE BATCH RELEASE. NO DRIFT WAS OBSERVED SINCE BATCH RELEASE. THE CUSTOMER'S PATIENT SAMPLE (DUFJO) (B)(6) WAS POSITIVE. THE CUSTOMER'S RESULTS WERE NOT REPRODUCED. SAMPLE (DUFJO) (B)(6) WAS TESTED WITHOUT SAMPLE / WITHOUT SPR (SOLID PHASE RECEPTACLE), AND BOTH RESULTS OBTAINED WERE = < 4 UA/ML NEGATIVE. IF THE CUSTOMER FORGOT SPR OR SAMPLE, THE RESULT WOULD BE AT = < 4 UA/ML NEGATIVE. THE CUSTOMER'S ISSUE WAS REPRODUCED WHEN SIMULATING AN OPERATOR ERROR (WITHOUT SRP OR SAMPLE). INSTRUMENT ISSUE CAN BE EXCLUDED AS QCV RESULTS CONFORMED TO EXPECTED SPECIFICATIONS. IN CONCLUSION, THE CUSTOMER'S NEGATIVE RESULT WAS NOT REPRODUCED INTERNALLY ON THE PATIENT RETURN SAMPLE. A POSITIVE RESULT WAS OBTAINED FOR THIS PATIENT SAMPLE (DUFJO) (B)(6) ON VIDAS CMV IGG LOT 1007040560/ 191112-0. THE INVESTIGATION'S PROBABLE HYPOTHESIS IS THE CUSTOMER RESULT IS AN OPERATOR ERROR DUE TO THE ABSENCE OF SPR OR SAMPLE. ACCORDING THE ABOVE DATA , THE KIT VIDAS CMV IGG LOT 1007040560/ 191112-0 IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE VIDAS® CMV IGG 60 TESTS (REFERENCE 30204, LOT1007040560). THE CUSTOMER REPORTED OBTAINING A NEGATIVE RESULT FOR A PATIENT SAMPLE PREVIOUSLY KNOWN TO BE CMV IGG POSITIVE. THE ASSAY WAS REPEATED, AND A POSITIVE RESULT WAS OBTAINED. THE CUSTOMER DID STATE THAT THERE WAS A 24-HOUR DELAY IN REPORTING RESULTS DUE TO THE REPEATED TEST. THE CUSTOMER CONFIRMED THE DISCREPANT RESULT HAD NO ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED. PRODUCT REFERENCE 30204 IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THE U.S. SIMILAR PRODUCT IS REFERENCE 30204-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648589 VIDAS® CMV IGG ASSAY VIDAS® CMV IGG ASSAY LFZ BIOMERIEUX SA 1007040560

    Patients

    Seq Age Sex Outcome Treatment
    1