BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® RUB IGG II - 30221

    MDR report key: 9595569 · Received January 16, 2020

    Report

    Report Number
    8020790-2020-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    March 20, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFX
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED FOR A CUSTOMER COMPLAINT OF FALSE NEGATIVE IGG RESULTS WHEN TESTING A PATIENT SAMPLE WITH VIDAS® RUBELLA IGG ASSAY (REF 30221, LOT 1007517570). THE CUSTOMER DID NOT SUBMIT THE PATIENT¿S SAMPLE FOR THE INVESTIGATION. BATCH HISTORY: THERE IS NO CAPA NOR NON-CONFORMITY RECORDED ON VIDAS RUB IGG II REF. 30221 LINKED TO CUSTOMER'S ISSUE BATCH HISTORY RECORDS VIDAS RUB IGG II REF. 30221 LOT 1007517570 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES LINKED TO THE CUSTOMER'S COMPLAINT. COMPLAINT TREND: NO RECURRENCE OF THE CUSTOMER'S ISSUE FOR THE IMPACTED LOT. CONTROL CHARTS: THE COMPLAINT LABORATORY OBSERVED FOUR (4) INTERNAL SAMPLES ON SEVEN (7) DIFFERENT BATCHES OF VIDAS RUB IGG II REF. 30221 INCLUDING LOT 1007517570. R181: 1 IU / ML; RANGES [0-3] IU / ML; R237: 5 IU / ML; RANGES [2-7] IU / ML; R100: 169 IU / ML; RANGES [112-227] IU / ML; R180: 221 IU / ML; RANGES [140-303] UI / ML. ALL RESULTS ARE WITHIN SPECIFICATIONS; CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED: THE COMPLAINT LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (R180 AND THREE OTHERS) WITH RETAIN KITS OF LOT 1007517570. THERE WAS NO ANOMALY; ALL VALUES ¿¿FOR EACH SAMPLE WERE WITHIN SPECIFICATION. THE COMPLAINT LABORATORY PERFORMED TWO (2) ADDITIONAL TESTS WITHOUT SAMPLE AND WITHOUT SPR. WITHOUT SAMPLE OR WITHOUT SPR THE RESULT IS NEGATIVE WITH 0RFV. CONCLUSION: NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS AND THE ANALYSIS OF QUALITY DATA. HYPOTHESIS: AS CUSTOMER'S ISSUE WAS REPRODUCED WHEN PERFORMING ANALYSIS WITHOUT SAMPLE OR SPR, THE NEGATIVE RESULT OBTAINED BY CUSTOMER MAY BE LINKED TO AN OPERATOR ERROR. WITHOUT CUSTOMER'S RETURN SAMPLE, THIS HYPOTHESIS CANNOT BE CONFIRMED AND WE CANNOT PURSUE FURTHER INVESTIGATION. THE INVESTIGATION CONCLUDED VIDAS RUB IGG II REF. 30221 LOT 1007517570 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® RUB IGG II 60 TESTS (REF. 30221, LOT 1007517570). THE CUSTOMER STATED THE PATIENT WAS A PREGNANT WOMAN WHO WAS CONFIRMED TO BE POSITIVE FOR RUBELLA IGG ONE MONTH PRIOR. THE SAMPLE WAS INITIALLY TESTED USING VIDAS® RUB IGG LOT 1007517570, AND OBTAINED A NEGATIVE RESULT OF 0 IU/ML. THE CUSTOMER TESTED THE SAMPLE TWO ADDITIONAL TIMES, BOTH REPEAT TESTS YIELDED POSITIVE RESULTS OF 223 UI/ML AND >400 UI/ML. ALTHOUGH REPEAT TESTING RESULTED IN A ONE (1) DAY DELAY IN REPORTING RESULTS, THE CUSTOMER CONFIRMED THE CORRECT RESULT OF POSITIVE WAS REPORTED TO THE TREATING PHYSICIAN. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60469 VIDAS® RUB IGG II - 30221 VIDAS® RUB IGG II - 30221 LFX BIOMERIEUX SA 1007517570

    Patients

    Seq Age Sex Outcome Treatment
    1