BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15928581 · Received December 6, 2022

    Report

    Report Number
    1221359-2022-10238
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 1, 2022
    Report Date
    February 15, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 168386 WITH 20 NORMAL HUMAN SERUM (NHS) SAMPLES AND 20 WHOLE BLOOD (WB) SAMPLES FROM THE SPECIFICITY PANEL, AND 1 OF EACH NEGATIVE NHS DILUENT, HIV-1, HIV-2, AND P24. 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: 168386, DEVICE PART NUMBER: 10732998/LOT:164848. 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 168386 SHOWED THAT THE CURRENT OVERALL INCIDENT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE DATE PROVIDED IN THE EVENT IS AN ESTIMATE AS THE EXACT DATE OF OCCURRENCE WAS NOT PROVIDED. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON OR BEFORE (B)(6) 2022. THIS MFR. REPORT IS ONE (1) OF TWO (2) AND IS IN REGARD TO LOT NUMBER 168386. THE QUANTITY OF FALSE RESULTS PER LOT NUMBER WAS NOT PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON OR BEFORE (B)(6) 2022. THIS MFR. REPORT IS ONE (1) OF TWO (2) AND IS IN REGARD TO LOT NUMBER 168386. THE QUANTITY OF FALSE RESULTS PER LOT NUMBER WAS NOT PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045015 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 168386 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown