BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9215355 · Received October 21, 2019

    Report

    Report Number
    1221359-2019-00070
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 18, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4). ON RETAINED KIT LOT 111287 WITH THE FOLLOWING INTERNAL SERUM/PLASMA AND WHOLE BLOOD SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 111287 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) RELATED TO LOT NUMBER 111287 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A (B)(6) ANTIGEN (AG) RESULT ON A EDTA PLASMA SAMPLE WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. REPEAT TESTING WAS PERFORMED ON THE SAME KIT LOT # YIELDING (B)(6) AG RESULTS. CONFIRMATION TESTING ON THE ABBOTT ARCHITECT AND BIORAD EVOLIS WAS (B)(6). THE PATIENT WAS REPORTED AS FEMALE. PREGNANCY STATUS, TREATMENT (ART) AND OUTCOME ARE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008007 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 111287 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1