BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7444386 · Received April 19, 2018

    Report

    Report Number
    1221359-2018-00029
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE SCARBOROUGH ON RETAINED KIT LOT 090955 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6), (B)(6), P24 POSITIVE, AND (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 090955 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBER 090955 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE SCARBOROUGH 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 FALSE POSITIVE AB RESULT WAS REPORTED ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE UNIGOLD RAPID TEST AS WELL AS A 4TH GENERATION EIA TEST WERE BOTH NEGATIVE AND A QUANTITATIVE PCR TEST WAS RNA <20 COPIES/ML ((B)(6) FOR (B)(6)). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288288 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 090955 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1