BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTI HIV-1/HIV-2 ANTIBODY TEST

    MDR report key: 7664019 · Received July 5, 2018

    Report

    Report Number
    3003871407-2018-00002
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    May 19, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BIOLYTICAL LABORATORIES INC.
    Product Code
    MZF
    PMA / PMN Number
    BP090032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOLYTICAL REQUESTED TEST KITS AND/OR PATIENT SAMPLES TO BE RETURNED FROM THE CUSTOMER SITE BUT NO RETURNED KITS OR PATIENT SAMPLE WERE RECEIVED. BIOLYTICAL THUS CONDUCTED AN INVESTIGATION OF BATCH RECORDS AND OTHER PRODUCTION DOCUMENTS RELATED TO INSTI HIV-1/HIV-2 ANTIBODY TEST, 90-1008, LOT 1706CB004 AND ALL RECORDS ARE FOUND SATISFACTORY. NO PREVIOUS CUSTOMER COMPLAINTS HAVE BEEN REPORTED FOR KIT LOT 1706CB004. NO OOSS OR NCRS HAVE BEEN INITIATED FOR THE KIT LOT OR ANY OF THE COMPONENT LOTS. INVESTIGATIONAL TESTING WAS PERFORMED USING RELEASED QC RETENTION KITS FROM LOT 1706CB004 WITH (B)(6) LIMIT OF DETECTION ((B)(6)) SAMPLES. ALL RESULTS WERE (B)(6) WITH (B)(6) TESTED AT N=10. NO NON-CONFORMITIES WERE OBSERVED, INDICATING THAT THE KIT PERFORMANCE IS NOT IMPACTED. AS CONFIRMED BY THE PATIENT'S (B)(6) RESULT WAS (B)(6) AND THE OTHER WAS (B)(6) WHICH IS CONSISTENT WITH AN (B)(6) WHO IS ABLE TO MAINTAIN OR "CONTROL" THE VIRUS AT VERY LOW LEVELS. SO ALTHOUGH THIS EVENT INVOLVES A POTENTIAL FOR SERIOUS INJURY, IT IS SPECIFIC TO A PATIENT SAMPLE TYPE AND NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE EVENT OCCURED IN (B)(6) AND IS BEING REPORTED TO THE FDA AS A FOREIGN EVENT. ONE PATIENT WAS TESTED (B)(6) WITH INSTI HIV TEST BUT (B)(6) WITH OTHER (B)(6) DIAGNOSTIC TESTS IN (B)(6). THE INSTI TEST WAS REPEATED AND THE RESULT WAS STILL (B)(6) UPON REPETITION. THE PATIENT HAD PREVIOUSLY DONE LAB TESTING FOR (B)(6) AND THE RESULTS WERE (B)(6). PATIENT THEN CONSULTED WITH A (B)(6) PRIMARY CARE PHYSICIAN, DR. (B)(6) IN (B)(6) WHO ORDERED A FULL TESTING PROFILE INCLUDING (B)(6). THE LABORATORY (B)(6) TEST WAS (B)(6), (B)(6), AND(B)(6) WAS (B)(6). ADDITIONAL TESTING I.E. (B)(6) AND (B)(6) TESTING ((B)(6)) WAS ORDERED BY THE PHYSICIAN. PATIENT'S BLOOD SAMPLE WAS TESTED IN DUPLICATE FOR (B)(6). ONE RESULT WAS (B)(6) AND THE OTHER WAS (B)(6). THE RESULTS WOULD BE CONSISTENT WITH AN (B)(6) WHO IS ABLE TO MAINTAIN OR "CONTROL" THE VIRUS AT VERY LOW LEVELS. THE INSTI HIV TEST KIT LOT INVOLVED IN THIS COMPLAINT WAS NOT DISTRIBUTED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506337 INSTI HIV-1/HIV-2 ANTIBODY TEST INSTI HIV-1/HIV-2 ANTIBODY TEST MZF BIOLYTICAL LABORATORIES INC. 90-1008 1706CB004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other