BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19725929 · Received July 11, 2024

    Report

    Report Number
    1221359-2024-00489
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 9, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 824739 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: 824739, TEST BASE PART NUMBER 10732998/ LOT: 820232. 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 824739 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON (B)(6) 2024 ON THREE (3) PATIENTS. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON (B)(6) 2024. CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD ON AN UNKNOWN DATE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON (B)(6) 2024 ON THREE (3) PATIENTS. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON (B)(6) 2024. CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD ON AN UNKNOWN DATE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236268 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 824739 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown