BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTI

    MDR report key: 5021091 · Received August 11, 2015

    Report

    Report Number
    3003871407-2015-00002
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    June 29, 2015
    Report Date
    August 11, 2015
    Manufacturer
    BIOLYTICAL LABORATORIES INC.
    Product Code
    MZF
    PMA / PMN Number
    BP090032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE MEMBRANE AND LOT 1501BA001 (EXPIRY DATE: 12/04/2015) AS WELL. THE MEMBRANE UNIT LOT WAS FOUND TO BE CONTAINED IN OTHER LOTS (1501BB001 AND 1501BA001) AND THEREFORE THIS FIELD CORRECTIVE ACTION WAS EXTENDED TO INCLUDE THESE LOTS. THESE BATCHES WERE NOT DISTRIBUTED IN THE US. (B)(4).

    Description of Event or Problem · 1

    (B)(6). BMU LOT 1412BG006 WHICH IS THE MEMBRANE UNIT OF LOT # 1412BA006. TESTING ON (B)(6) 2015: A TOTAL OF 36 BMUS FROM LOT 1412BG006 (DOM: 12/04/2014, EXP.: 12/04/2015) WERE TESTED USING THE SAME LOTS OF MATCHING SOLUTIONS (SAMPLE DILUENT: 1411BH007, COLOR DEVELOPER: 1412BJ008, CLARIFYING SOLUTION: 1412BK003). THE BMUS WERE TESTED WITH THREE DIFFERENT LOTS OF NEGATIVE WHOLE BLOOD AT N=10 AND WITH LOW POSITIVE CONTROL AND POSITIVE SERUM AT N=3. NEGATIVE WHOLE BLOOD LOTS#: 301001-15100, 301001-15101 AND 301001-15102. LOW POSITIVE CONTROL LOT: RD001LPC. POSITIVE SERUM LOT#: PS1508. RESULTS: ONE FALSE REACTIVE RESULT WAS DETECTED (TEST # 11) WITH NEGATIVE WHOLE BLOOD 301001-15101. ALL OTHER RESULTS WERE AS EXPECTED. FOLLOW UP TESTING ON (B)(6) 2015: A TOTAL OF 30 BMUS FROM LOT 1412BG006) WERE TESTED USING THE SAME LOTS OF MATCHING SOLUTIONS (SAMPLE DILUENT: 1411BH007, COLOR DEVELOPER: 1412BJ008 AND 1501YW007, CLARIFYING SOLUTION: 1412BK003). THE BMUS WERE TESTED WITH THREE DIFFERENT LOTS OF NEGATIVE WHOLE BLOOD AT N=10. NEGATIVE WHOLE BLOOD LOTS: 301001-15100, 301001-15101 AND 301001-15102. RESULTS: TWO FALSE REACTIVE RESULT WERE DETECTED (TEST #11 AND 12) WITH NEGATIVE WHOLE BLOOD 301001-15101. ALL OTHER RESULTS WERE AS EXPECTED. DISCUSSION/CONCLUSION: ALL THREE NEGATIVE WHOLE BLOODS WERE USED IN QC FUNCTIONAL TESTING TO RELEASE THE COLOR DEVELOPER LOT# 1507YW055 AND BMU LOT# 1507CG030. ALL SAMPLES WERE TESTED AT N=3 PER LOT. THUS, RULING OUT ANY DISCREPANCIES WITH THE WHOLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526049 INSTI HIV-1/HIV-2 ANTIBODY TEST KIT MZF BIOLYTICAL LABORATORIES INC. 90-1016 1412BA006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention