BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7696338 · Received July 17, 2018

    Report

    Report Number
    1221359-2018-00465
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    April 13, 2018
    Report Date
    July 17, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOT 091493 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6) . ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 091493 WAS REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 091493 SHOWED THAT THE COMPLAINT RATE WAS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONFLICTING AG RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO TEST ON A SERUM PATIENT SAMPLE. THE TEST WAS INITIALLY (B)(6) FOR AG AND UPON REPEAT TESTING WITH THE SAME SAMPLE AND SAME LOT WAS NEGATIVE. BASED ON THE INFORMATION AVAILABLE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE CONFLICTING ALERE DETERMINE HIV 1/2 AG/AB COMBO TESTS. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND , 2018 AT ALERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536016 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 091493 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR