BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    MDR report key: 23008549 · Received September 9, 2025

    Report

    Report Number
    1221359-2025-00357
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    January 1, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000993124 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 0000993124 AND DEVICE PART NUMBER 10732998 LOT 992853. 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 0000993124 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO ASSAY PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN SAMPLE TYPES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO ASSAY PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN SAMPLE TYPES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831601 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000993124 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown