BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20752256 · Received November 21, 2024

    Report

    Report Number
    1221359-2024-00687
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    September 9, 2024
    Report Date
    January 8, 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
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE STILL PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OR UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 877155 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 877155 AND DEVICE PART NUMBER 10732998 / LOT 874665. 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 877155 SHOWED THAT THE COMPLAINT RATE IS 0.00823%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST OVER MULTIPLE DATES. THIS REPORT IS FOR PATIENT 1 (TEST QUANTITY 2), TEST SIX (6) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A REPEAT TEST WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST TAKEN ON (B)(6) 2024. CONFIRMATORY TESTING WAS PERFORMED WITH AN ALINITY SCREENING TEST FOR P24 AT A SEPARATE FACILITY (DATE UNKNOWN) AND A NEGATIVE RESULT WAS RECEIVED. NO PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST OVER MULTIPLE DATES. THIS REPORT IS FOR PATIENT 1 (TEST QUANTITY 2), TEST SIX (6) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A REPEAT TEST WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST TAKEN ON (B)(6) 2024. CONFIRMATORY TESTING WAS PERFORMED WITH AN ALINITY SCREENING TEST FOR P24 AT A SEPARATE FACILITY (DATE UNKNOWN) AND A NEGATIVE RESULT WAS RECEIVED. NO PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255366 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 877155 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown