BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7591058 · Received June 12, 2018

    Report

    Report Number
    1221359-2018-00311
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Report Date
    June 12, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED TWO KIT LOTS DURING THE INVESTIGATION. TESTING WAS PERFORMED ON RETAINED KIT LOTS 090021 AND 170406 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES:(B)(6). THE KITS PERFORMED AS EXPECTED. ADDITIONALLY, QC DATA AND BATCH RECORDS FOR LOTS 090021 AND 170406 WERE REVIEWED. RELEASE TESTING WAS VALID AND THE LOTS WERE FOUND TO BE PERFORMING AS EXPECTED. IN ADDITION, THE CUSTOMER'S RETURNED RETAINED SAMPLES FROM KIT LOTS 090021 AND 170406 WERE TESTED WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES:(B)(6). THE TESTS PERFORMED AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) RELATED TO LOT NUMBER 090021 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED (B)(6) RELATED TO LOT NUMBER 170406 SHOWED THAT THE COMPLAINT RATE IS 0.003%. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. IN HOUSE TESTING 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 (B)(6) RESULTS ON UNKNOWN SAMPLE TYPES FROM AN UNKNOWN NUMBER OF PATIENTS TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. NO CONFIRMATORY TEST WAS REPORTED. NO DATE OF EVENT WAS PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, 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), INC. ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435903 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 090021 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1