BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7345360 · Received March 16, 2018

    Report

    Report Number
    1221359-2018-00006
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    December 30, 2017
    Report Date
    March 16, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED BY ALERE (B)(4) ON RETAINED KIT LOT# 091493. THE RETENTION LOT TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES. THE MANUFACTURING BATCH RECORD REVIEW FOR LOT 091493 DID NOT REVEAL ANY FAILURES OF ACCEPTANCE CRITERIA. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. 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 REPORTING FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 091493 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS. NOTE: THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH - MARCH 2ND AT ALERE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) RESULT WAS OBTAINED WITH THE ALERE DETERMINE HIV ½ AG/AB COMBO TEST ON A LABOR AND DELIVERY PATIENT. THE PATIENT WAS CONFIRMED (B)(6) BY ABBOTT ARCHITECH. IT IS UNKNOWN WHAT WEEK OF PREGNANCY THE PATIENT WAS IN AT THE TIME OF THE TESTING OR IF/WHEN THE PATIENT DELIVERED. NO ADVERSE OUTCOME WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189911 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 091493 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1