BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 8865200 · Received August 6, 2019

    Report

    Report Number
    1221359-2019-00048
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 5, 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
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 107038 WITH THE FOLLOWING INTERNAL WHOLE BLOOD AND SERUM/PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 107038 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) RELATED TO LOT NUMBER 107038 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), INC. 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

    THIS REPORT REPRESENTS THE EIGHTH OF 15 ANTIBODY (AB) (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS REPORTED BY A CUSTOMER TO AN ABBOTT SALES REPRESENTATIVE. CONFIRMATORY TESTING WAS (B)(6) ON A 4TH GENERATION HIV TEST (NOT OTHERWISE SPECIFIED). THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE NOT REPORTED. 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
    661807 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 107038 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1