BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19816725 · Received July 24, 2024

    Report

    Report Number
    1221359-2024-00513
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    May 31, 2024
    Report Date
    September 26, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 826106 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 826106, TEST BASE PART NUMBER 10732998 / LOT 823684. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 826106 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2024 ON A SERUM SAMPLE. CONFIRMATORY PCR TESTING WAS PERFORMED ON THE OTHER SITE ON AN UNKNOWN DATE WHICH GENERATED A POSITIVE RESULT. THE CUSTOMER MENTIONED THAT THE PATIENT WAS NOT ON ART TREATMENT. NO ADDITIONAL TESTING (ELISA TEST, MOLECULAR TEST) WAS PERFORMED. THE CUSTOMER DOES NOT KNOW IF THERE WERE ANY NEGATIVE IMPACT TO THE PATIENT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB PERFORMED ON (B)(6) 2024 ON A SERUM SAMPLE. CONFIRMATORY PCR TESTING WAS PERFORMED ON THE OTHER SITE ON AN UNKNOWN DATE WHICH GENERATED A POSITIVE RESULT. THE CUSTOMER MENTIONED THAT THE PATIENT WAS NOT ON ART TREATMENT. NO ADDITIONAL TESTING (ELISA TEST, MOLECULAR TEST) WAS PERFORMED. THE CUSTOMER DOES NOT KNOW IF THERE WERE ANY NEGATIVE IMPACT TO THE PATIENT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366479 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 826106 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male