BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9474813 · Received December 16, 2019

    Report

    Report Number
    1221359-2019-00087
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Report Date
    December 16, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOT DIAGNOSTICS (B)(6) ON RETAINED KIT LOT 111287 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 111287 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS: (CONFIRMED AND UNCONFIRMED) CONFLICTING RESULTS 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)(6) 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

    A CUSTOMER REPORTED OBSERVING A "WHITE LINE" (NO PINK) ON THE ANTIGEN (AG) LINE WHEN PERFORMING ALERE DETERMINE (B)(6) COMBO TEST (SAMPLE TYPE NOT PROVIDED). THE CUSTOMER REPEATED THE TEST (SAMPLE TYPE UNKNOWN) ON THE SAME ALERE DETERMINE (B)(6) COMBO KIT LOT AND OBSERVED "A LITTLE PINK" ON THE AG LINE. CONFIRMATION TESTING (TESTING METHODOLOGY NOT OTHERWISE SPECIFIED) WAS (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND OUTCOME ARE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THE ALERE DETERMINE (B)(6) COMBO PRODUCT INSERT PROVIDES IMAGES OF RESULT INTERPRETATION. NONREACTIVE TEST RESULTS ARE SHOWN AS WHITE LINES IN THE ANTIGEN AND ANTIBODY TEST AREA. ALTHOUGH WHITE LINES ARE NOT AN UNUSUAL OR UNEXPECTED OCCURRENCE, IT IS EXPECTED THAT TESTING THE SAME PATIENT SAMPLE OR A SECOND SAMPLE FROM THE SAME PATIENT TESTED ON THE SAME DAY AS THE ORIGINAL SAMPLE WOULD RETURN THE SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267627 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