BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20421363 · Received October 10, 2024

    Report

    Report Number
    1221359-2024-00641
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 29, 2024
    Report Date
    November 20, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 874643 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: 874643, 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 FALSE POSITIVE RESULT WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON (B)(6) 2024 USING SERUM SAMPLE. REPEAT TESTING WAS PERFORMED TWICE WITH TEST STRIPS FROM SAME LOT ON (B)(6) 2024 WITH SERUM SAMPLE WHICH GENERATED NEGATIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH UNKNOWN TEST TYPE IN A LABORATORY WITH SERUM SAMPLE THAT GENERATED NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULT WITH THE DETERMINE HIV-1/2 AG/AB COMBO TEST KIT PERFORMED ON (B)(6) 2024 USING SERUM SAMPLE. REPEAT TESTING WAS PERFORMED TWICE WITH TEST STRIPS FROM SAME LOT ON (B)(6) 2024 WITH SERUM SAMPLE WHICH GENERATED NEGATIVE RESULTS. ADDITIONAL TESTING WAS PERFORMED WITH UNKNOWN TEST TYPE IN A LABORATORY WITH SERUM SAMPLE THAT GENERATED NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933481 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 Female