BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 7183671 · Received January 11, 2018

    Report

    Report Number
    1221359-2018-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 4, 2017
    Report Date
    January 11, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES. THE MANUFACTURING BATCH RECORD REVIEW DID NOT REVEAL ANY FAILURES OF ACCEPTANCE CRITERIA. 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. A REVIEW OF THE COMPLAINTS REPORTED FOR THIS PHENOMENON RELATED TO LOT NUMBER 092445 SHOWED THAT THE COMPLAINT RATE IS 0.014%. EVIDENCE AVAILABLE DOES NOT INDICATE THAT THIS DEVICE LOT IS PERFORMING OUTSIDE OF LABEL CLAIMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A (B)(6) RESULT WITH A SERUM SAMPLE FROM A LABOR AND DELIVERY PATIENT ON DETERMINE HIV-1/2 AG/AB COMBO. SUBSEQUENT CONFIRMATORY TESTING DEMONSTRATED (B)(6) RESULTS. THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27640 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH, INC. 092445 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1