BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9746731 · Received February 24, 2020

    Report

    Report Number
    1221359-2020-00009
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 4, 2020
    Report Date
    February 24, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010323
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(6) ON RETAINED KIT LOT 114861 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 LOT 114861 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) (CONFIRMED AND UNCONFIRMED) RELATED TO LOT NUMBER 114861 SHOWED THAT THE COMPLAINT RATE IS (B)(6). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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 A (B)(6) (AG/AB NOT OTHERWISE SPECIFIED) RESULT ON A SERUM SAMPLE WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. CONFIRMATION TESTING (METHODOLOGY NOT OTHERWISE SPECIFIED) WAS (B)(6). THE PATIENT WAS REPORTED AS A PREGNANT FEMALE (FIRST TRIMESTER). THE CUSTOMER STATED THEY "DIDN'T BELIEVE" ART WAS ADMINISTERED BASED ON THE ALERE DETERMINE HIV-1/2 AG/AB RESULTS. THE CUSTOMER REPORTED THERE WAS NO DEATH, SERIOUS INJURY OR SURGICAL PROCEDURES PERFORMED BASED ON THE RESULTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT TREATMENT AND PATIENT OUTCOME ARE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL PATIENT INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208173 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 114861 10811877010323

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR