BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15908149 · Received December 2, 2022

    Report

    Report Number
    1221359-2022-10224
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 7, 2022
    Report Date
    January 31, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 196548 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 KIT PART NUMBER 7D2648 / LOT 196548 AND DEVICE PART NUMBER 10732998 / LOT 191389. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 196548 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE OR TEST PROCEDURE. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON 07NOV2022. THIS MFR REPORT ADDRESSES TEST TWO (2) OF TWO (2) AND LOT NUMBER 196548 (QUANTITY 1). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON (B)(6)2022. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON (B)(6) 2022. THIS MFR REPORT ADDRESSES TEST TWO (2) OF TWO (2) AND LOT NUMBER 196548 (QUANTITY 1). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON (B)(6) 2022. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797271 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 196548 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown