BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9454243 · Received December 11, 2019

    Report

    Report Number
    1221359-2019-00085
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 10, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER AND PATIENT'S MEDICAL HISTORY, WAS NOT AVAILABLE AND THEREFORE A ROOT CAUSE INVESTIGATION WAS NOT PERFORMED. A REVIEW OF COMPLAINTS' TREND REVEAL THAT ALL OF THE ALERE DETERMINE (B)(6) AG/AB COMBO BATCHES ARE PERFORMING ACCORDING TO LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FALSE POSITIVE RESULTS ON TWO (2) PATIENTS. THE CUSTOMER ONLY PROVIDED INFORMATION ON PATIENT 1. THIS REPORT REPRESENTS PATIENT 2. THE CUSTOMER REPORTED A FALSE POSITIVE AG (ANTIGEN) RESULT WITH THE ALERE DETERMINE (B)(6) AG/AB COMBO TEST. SAMPLE TYPE, REPEAT TESTING AND CONFIRMATION TESTING ARE UNKNOWN. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND OUTCOME ARE UNKNOWN. THE CUSTOMER REPORTED THAT PATIENT 2 WAS "REPORTED AS NEGATIVE AND PATIENT INFORMATION WASN'T SAVED." THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245228 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1