BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21704538 · Received March 27, 2025

    Report

    Report Number
    1221359-2025-00141
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    January 14, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037
    Removal / Correction Number
    1221359-07/31/2025-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 0000952264 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 0000952264, DEVICE PART NUMBER 10732998 / LOT 945414. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 0000952264 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 0000952264, THE ROOT CAUSE OF THE RESULTS WAS DUE TO A SUBCOMPONENT USED IN THE MANUFACTURE OF DETERMINE HIV-1/2 AG/AG COMBO. THE ISSUE HAS BEEN ISOLATED TO SPECIFIC LOTS OF THE SUBCOMPONENT, WHICH WERE USED TO MANUFACTURE SPECIFIC TEST KIT LOTS. THE NECESSARY ACTIONS TO PREVENT RECURRENCE HAVE BEEN TAKEN, AND THE CORRECTION OF PRODUCT IN THE FIELD WAS CONDUCTED.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWENTY-FOUR (24) FALSE POSITIVE RESULTS WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED USING DIFFERENT LOTS ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST SEVENTEEN (17) OF TWENTY-FOUR (24) WITH LOT 0000952264. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON UNKNOWN DATE USING FINGERSTICK SAMPLE. CONFIRMATORY TESTING WAS PERFORMED USING UNKNOWN PLATFORM ON AN UNKNOWN DATE WHICH GENERATED NEGATIVE RESULT. NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWENTY-FOUR (24) FALSE POSITIVE RESULTS WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED USING DIFFERENT LOTS ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST SEVENTEEN (17) OF TWENTY-FOUR (24) WITH LOT 0000952264. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON UNKNOWN DATE USING FINGERSTICK SAMPLE. CONFIRMATORY TESTING WAS PERFORMED USING UNKNOWN PLATFORM ON AN UNKNOWN DATE WHICH GENERATED NEGATIVE RESULT. NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417048 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000952264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown