BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14804578 · Received June 24, 2022

    Report

    Report Number
    1221359-2022-03300
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    October 14, 2021
    Report Date
    June 24, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 161479 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 161479, TEST BASE PART NUMBER 10732998 / LOT 161479. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A (B)(6) RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST PERFORMED ON 14OCT2021. CONFIRMATION TESTING WAS PERFORMED USING BIORAD HIV COMBO AG/AB EIA, GENERATED A (B)(6) RESULT. THE CUSTOMER STATED THERE WAS A POSSIBLE C-SECTION DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS A LIVE BIRTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890061 ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 161479 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other