BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7597337 · Received June 13, 2018

    Report

    Report Number
    1221359-2018-00256
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    March 3, 2017
    Report Date
    June 13, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE COMPLAINT AND INVESTIGATION, THE REPORTED LOT 160808 WAS EXPIRED AND UNABLE TO BE TESTED. HOWEVER, THE LOT WAS WITHIN EXPIRATION DATE WHEN USED FOR TESTING AT THE CUSTOMER SITE. THE MANUFACTURING BATCH RECORDS FOR LOT 160808 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOT 161027 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 161027 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) RELATED TO LOT NUMBER 160808 AND 161027 SHOWED THAT THE COMPLAINT RATES WERE (B)(4) RESPECTIVELY. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. 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. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A FALSE (B)(6) RESULT WAS REPORTED ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE CUSTOMER REPORTED THE PATIENT WAS TESTED TWICE WITH ALERE DETERMINE HIV 1/2 AG/AB COMBO TESTS ON TWO DIFFERENT OCCASIONS AND AT 2 DIFFERENT LOCATIONS. THE FIRST RESULT WAS (B)(6) (LOT 160808 EXP.12/19/2017) AND THE SECOND WAS (B)(6) (LOT 161027 EXP. 04/05/2018). IT IS UNKNOWN HOW MUCH TIME TRANSPIRED BETWEEN TEST EVENTS. IT IS UNKNOWN IF THE SAME SAMPLE OR DIFFERENT SAMPLES WERE USED FOR THESE TESTS. THE PATIENT WAS CONFIRMED (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. 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)(6), INC. ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439372 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 160808 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1