BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7598602 · Received June 13, 2018

    Report

    Report Number
    1221359-2018-00189
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    April 15, 2017
    Report Date
    June 14, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE ON RETAINED KIT LOT 161218 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 161218 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 161218 SHOWED A COMPLAINT RATE OF (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE 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. ALERE WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A NEEDLE STICK OCCURRED AFTER A FEMALE PATIENT GAVE BIRTH AND AS A RESULT OF THE NEEDLE STICK EVENT THE PATIENT WAS TESTED WITH ALERE DETERMINE HIV-1/2 AG/AB COMBO. A (B)(6) AB RESULT WAS REPORTED WITH A SAMPLE ON THE ALERE DETERMINE¿ HIV-1/2 AG/AB COMBO TEST. THE PATIENT SAMPLE WAS SENT FOR CONFIRMATORY TESTING AND CAME BACK (B)(6), HOWEVER DUE TO THE (B)(6) ALERE DETERMINE HIV-1/2 AG/AB COMBO RESULT THE NURSE THAT WAS INVOLVED IN THE NEEDLE STICK WAS PROVIDED PROPHYLACTIC TREATMENT. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. HOWEVER, SINCE THE NURSE THAT WAS INVOLVED WITH THE NEEDLE STICK'S PREGNANCY STATUS AND PATIENT OUTCOME WERE UNKNOWN THIS EVENT IS BEING REPORTED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND , 2018 AT ALERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439444 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 161218 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1