BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21878465 · Received April 21, 2025

    Report

    Report Number
    1221359-2025-00218
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    February 5, 2025
    Report Date
    October 6, 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
    NM, 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. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2 - AGE AT TIME OF EVENT, AGE UNITS (PATIENT). A3A - SEX. B3 - DATE OF EVENT. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 - DESCRIBE EVENT OR PROBLEM (THIS EVENT NOW INCLUDES SEVEN (7) REPORTS. FIVE (5) INITIAL REPORT WILL BE SUBMITTED SEPARATELY.) 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 0000950115 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 0000950115, DEVICE PART NUMBER 10732998/LOT 945412. 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 0000950115 SHOWED THAT THE COMPLAINT RATE IS (B)(4). AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 0000950115, 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON UNKNOWN DATE USING FINGERSTICK SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED WITH HIV 1/2 GEN 4 GEENIUS REFLEX TEST ON UNKNOWN DATE USING VENOUS SAMPLE WHICH GENERATED NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON UNKNOWN DATE USING FINGERSTICK SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED WITH HIV 1/2 GEN 4 GENIUS REFLEX TEST ON UNKNOWN DATE USING VENOUS SAMPLE WHICH GENERATED NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF SEVEN (7). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV-1/2 AG/AB COMBO TEST PERFORMED ON UNKNOWN DATE USING FINGERSTICK SAMPLE TYPE. CONFIRMATORY TESTING WAS PERFORMED WITH HIV 1/2 GEN 4 GEENIUS REFLEX TEST ON UNKNOWN DATE USING VENOUS SAMPLE WHICH GENERATED NEGATIVE RESULT. THE CUSTOMER CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261182 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000950115

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female