BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7289667 · Received February 22, 2018

    Report

    Report Number
    1221359-2018-00004
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 10, 2018
    Report Date
    February 22, 2018
    Manufacturer
    ALERE SCARBOROUGH
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTS WERE PERFORMED ON RETAINED LOT 090955 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROLS: (B)(6). RESULTS WERE AS EXPECTED. QUALITY CONTROL RELEASE RECORDS FOR LOT 090955 WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATIONS. ONLY ONE OTHER SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS LOT ((B)(4). ALERE (B)(4) WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THE LOT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO USING A FINGERSTICK SAMPLE. AS PER THEIR PROTOCOLS, A 4TH GENERATION TEST WAS PERFORMED DURING THE SAME VISIT. THIS HIV-1 RNA QUALITATIVE TEST WAS (B)(6). ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER ON (B)(6) 2018 INDICATED THAT THE PATIENT HAD (B)(6) TESTING TO CONFIRM THE INFECTION. THE RESULTS OF THE TITER TESTING WAS(B)(6) WHICH IS ABOVE THE NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134595 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH 090955 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1