BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21757561 · Received April 2, 2025

    Report

    Report Number
    1221359-2025-00163
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    February 1, 2025
    Report Date
    September 24, 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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: 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 0000930923 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 0000930923, DEVICE PART NUMBER 10732998 / LOT 938702. 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 930923 SHOWED THAT THE COMPLAINT RATE IS (B)(4). AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 0000930923, 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 - DATE OF EVENT: 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.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. ADDITIONAL INFORMATION: E1 - FULL ADDRESS PROVIDED THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AB/AG COMBO TEST WITH WHOLE BLOOD SAMPLE PERFORMED ON AN UNKNOWN DATE. THIS REPORT ADDRESSES PATIENT THREE (3) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AB/AG COMBO TEST WITH A WHOLE BLOOD SAMPLE PERFORMED ON AN UNKNOWN DATE. A CONFIRMATORY TEST WAS PERFORMED AT AN RNA BLOOD CONFIRMATORY LAB (METHOD UNKNOWN). THE RESULT WAS NEGATIVE. ALTHOUGH REQUESTED, NO INFORMATION ABOUT THE PATIENT, THEIR TREATMENT, OR OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AB/AG COMBO TEST WITH WHOLE BLOOD SAMPLE PERFORMED ON AN UNKNOWN DATE. THIS REPORT ADDRESSES PATIENT THREE (3) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AB/AG COMBO TEST WITH A WHOLE BLOOD SAMPLE PERFORMED ON AN UNKNOWN DATE. A CONFIRMATORY TEST WAS PERFORMED AT AN RNA BLOOD CONFIRMATORY LAB (METHOD UNKNOWN). THE RESULT WAS NEGATIVE. ALTHOUGH REQUESTED, NO INFORMATION ABOUT THE PATIENT, THEIR TREATMENT, OR OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AB/AG COMBO TEST WITH WHOLE BLOOD SAMPLE PERFORMED ON AN UNKNOWN DATE. THIS REPORT ADDRESSES PATIENT THREE (3) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AB/AG COMBO TEST WITH A WHOLE BLOOD SAMPLE PERFORMED ON AN UNKNOWN DATE. A CONFIRMATORY TEST WAS PERFORMED AT AN RNA BLOOD CONFIRMATORY LAB (METHOD UNKNOWN). THE RESULT WAS NEGATIVE. ALTHOUGH REQUESTED, NO INFORMATION ABOUT THE PATIENT, THEIR TREATMENT, OR OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423363 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000930923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown