BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19372753 · Received May 22, 2024

    Report

    Report Number
    1221359-2024-00387
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    February 14, 2024
    Report Date
    July 8, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 820064 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: 820064, TEST BASE PART NUMBER 10732998/ LOT: 809186. 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 820064 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON VARIOUS DATES ON SIX (6) PATIENTS. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF SIX (6). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON (B)(6) 2024 ON A BLOOD SAMPLE. 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 SIX (6) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON VARIOUS DATES ON SIX (6) PATIENTS. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF SIX (6). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON (B)(6) 2024 ON A BLOOD SAMPLE. 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
    1750212 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 820064 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female