BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20939557 · Received December 16, 2024

    Report

    Report Number
    1221359-2024-00713
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 13, 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
    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

    CORRECTION: D8 - WAS DEVICE SERVICED BY THIRD PARTY?: FROM NONE SELECTED TO NA. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 874643 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS AND DILUENT. 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 874643 AND DEVICE PART NUMBER 10732998 / LOT 866255. 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 874643 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 SAMPLES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB FOR TWO PATIENTS PERFORMED ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2024. CONFIRMATORY PCR TESTING WAS PERFORMED ON AN UNKNOWN DATE TO CONFIRM HIV RESULTS. RESULTS ARE UNKNOWN. THE CUSTOMER CONFIRMED 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 ALERE DETERMINE HIV 1/2 AG/AB FOR TWO PATIENTS PERFORMED ON (B)(6) 2024 AND (B)(6) 2024. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2024. CONFIRMATORY PCR TESTING WAS PERFORMED ON AN UNKNOWN DATE TO CONFIRM HIV RESULTS. RESULTS ARE UNKNOWN. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390630 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 874643 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown