BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 12194440 · Received July 20, 2021

    Report

    Report Number
    1221359-2021-02056
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 23, 2021
    Report Date
    April 1, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 153829 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648 / LOT 153829 AND TEST BASE PART NUMBER 10732998 / LOT 152121. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 153829 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD BE ATTRIBUTED TO THE SPECIFIC PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (B)(6) RESULTS WITH THE ALERE DETERMINE HIV ¿ AG/AB COMBO TEST PERFORMED ON (B)(6) 2021. THE CUSTOMER REPORTED TESTING A WHOLE EDTA BLOOD SAMPLE AND RETESTING AND RETESTING WAS PERFORMED 2X WITH THE SAME BOX AND 1X ON AN UNOPENED BOX. THREE TOTAL STRIPES WERE STRIPS WERE TESTED. THE SERUM AND PLASMA SAMPLES WERE ADDED TO THE TESTS BY MLA PIPPETTE. BOTH TESTS GENERATED ANTIBODY (AB) (B)(6) RESULTS. CONFIRMATION TESTING WAS PERFORMED AND SENT TO (B)(6) (DIAGNOSTIC METHODOLOGY NOT PROVIDED) GENERATED (B)(6) RESULTS. THE PATIENT WAS NOT KNOWN TO BE (B)(6) AT THE TIME OF TESTING. THE (B)(6) YEAR OLD FEMALE IN LABOR AND DELIVERY. THE TEST WAS PERFORMED PRIOR TO DELIVERY. THE PATIENT DID NOT RECEIVE ART BASED ON THE ALERE DETERMINE HIV-1/2 AG/AB COMBO RESULTS. THE PATIENT EXPERIENCED A 'NORMAL' VAGINAL DELIVERY. THE CUSTOMER REPORTED THAT (B)(6) DRUGS WERE ADMINISTERED TO THE BABY. THERE WAS NO DEATH OR SERIOUS INJURY TO THE PATIENT BASED ON THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096600 DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 153829 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female