BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 8159446 · Received December 13, 2018

    Report

    Report Number
    1221359-2018-00551
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 13, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOTS 102459 AND 101439 WITH THE FOLLOWING INTERNAL SERUM PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOTS 102459 AND 101439 WERE REVIEWED. THESE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) RELATED TO LOTS 102459 AND 101439 SHOWED THAT THE COMPLAINT RATE IS (B)(4), RESPECTIVELY. 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 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 THESE DEVICE LOTS ARE PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED (B)(6) RESULTS ON A SERUM PLASMA SAMPLE WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. A TOTAL OF 4 TEST STRIPS FROM 2 DIFFERENT LOTS WERE TESTED FOR THE SINGLE REPORTED PATIENT. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE RESULTS OF A (B)(6) TEST WERE UNKNOWN AT THE TIME OF REPORTING. IT WAS INDICATED THAT THE FEMALE PATIENT WAS PREGNANT. THE PATIENT'S TREATMENT AND OUTCOME WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999582 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 102459 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR