BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7654323 · Received June 29, 2018

    Report

    Report Number
    MW5078178
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    April 30, 2018
    Report Date
    June 28, 2018
    Manufacturer
    ABBOTT GMBH & CO. KG / ALERE SCARBOROUGH, INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT (B)(6) WAS A SEXUAL/INJECTION DRUG CONTACT TO A PT RECENTLY DIAGNOSED WITH ACUTE (B)(6)INFECTION. PT (B)(6) WAS TESTED VIA FINGERSTICK WHOLE BLOOD FOR (B)(6) INFECTION USING THE ALERE DETERMINE HIV 1/2 AG/AB TEST. PT (B)(6) TEST RESULT WAS (B)(6). AT THE SAME TIME, A SERUM SAMPLE WAS COLLECTED AND SUBMITTED TO A LOCAL LAB FOR HIV AG/AB COMBO TESTING (4TH GENERATION) AND HIV-1 RNA NUCLEIC ACID AMPLIFICATION TESTING. THE LAB RESULT ON THE HIV COMBO TEST WAS REPEATEDLY (B)(6), AND THE HIV-1 RNA NAT TEST WAS (B)(6). TIME FROM LAST EXPOSURE TO DATE OF SPECIMEN COLLECTION UNCERTAIN, BUT ESTIMATE IS 18 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495787 ALERE DETERMINE HIV 1/2 AG/AB COMBO ALERE DETERMINE MZF ABBOTT GMBH & CO. KG / ALERE SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other