BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTI HIV-1/HIV-2 ANTIBODY TEST

    MDR report key: 11838576 · Received May 17, 2021

    Report

    Report Number
    3003871407-2021-00003
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 16, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BIOLYTICAL LABORATORIES INC
    Product Code
    MZF
    UDI-DI
    00686597010198
    PMA / PMN Number
    BP090032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. IT IS WELL DOCUMENTED IN THE IFU AND A KNOWN LIMITATION THAT USING THIS DEVICE WHILE ON ART THAT IT COULD LEAD TO PERFORMANCE ISSUES WITH THE DEVICES. IN THIS CONTEXT, PATIENT TESTED WAS KNOWN HIV POSITIVE. INITIALLY IT WAS UNDERSTOOD THAT THE PATIENT WAS ON ART MEDICATION. HOWEVER, AFTER A SECOND CALL WITH CLINIC IT IS UNKNOWN IF THE PATIENT WAS TAKING ART MEDICATION. NO CONFIRMATORY TESTS WAS ON THE PATIENT. THIS IS A COMBINED INITIAL AND FINAL MEDICAL DEVICE REPORT FOR THIS EVENT. THERE WON'T BE ANY ADDITIONAL FOLLOW-UP REPORTS TO BE SUBMITTED TO THIS UNLESS REQUESTED BY THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE RESULTS WITH INSTI HIV-1/HIV-2 ANTIBODY TEST. PATIENT WAS KNOWN (B)(6). INITIALLY IT WAS UNDERSTOOD THAT THE PATIENT WAS ON ART MEDICATION. HOWEVER, AFTER A SECOND CALL WITH THE CLINIC, IT IS UNKNOWN IF THE PATIENT IS TAKING ART MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735525 INSTI HIV-1/HIV-2 ANTIBODY TEST INSTI HIV TEST MZF BIOLYTICAL LABORATORIES INC 90-1019 1019200052 00686597010198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other