BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7592843 · Received June 12, 2018

    Report

    Report Number
    1221359-2018-00215
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    August 16, 2017
    Report Date
    June 12, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOT 170222 AND 170503 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: HIV-1 POSITIVE, HIV-2 POSITIVE, P24 POSITIVE, AND HIV NEGATIVE. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 170222 AND 170503 WERE REVIEWED. THESE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. THE CUSTOMER RETURNED THE PATIENT'S SERUM SAMPLE AND IT WAS TESTED WITH THE SAME DEVICES FROM BOTH KIT LOTS OF RETAIN DEVICES. THE POSITIVE RESULT WAS REPLICATED WITH BOTH LOTS. TESTING OF THE RETURNED PATIENT SAMPLE IS INTENDED TO REPLICATE THE CUSTOMER'S REPORTED ISSUE. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 170222 AND 170503 SHOWED THAT THE COMPLAINT RATE ARE (B)(4) AND (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 (B)(6) RESULT WAS REPORTED ON AN EDTA WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO FROM A (B)(6) PREGNANT WOMAN. AT THE TIME OF TESTING, THE PATIENT WAS (B)(6) PREGNANT, BUT NOT IN ACTIVE LABOR. THE TEST WAS REPEATED AND THE SAME RESULT WAS OBTAINED. THE TEST WAS REPEATED ONE ADDITIONAL TIME USING SERUM AND OBTAINED A (B)(6) RESULT ((B)(6)). BOTH EDTA WHOLE BLOOD AND SERUM SAMPLES WERE REPEATED ON LOT 170503 AND A (B)(6) RESULT WAS OBTAINED FOR BOTH SAMPLE TYPES. THE PATIENT WAS CONFIRMED (B)(6) BY ABBOTT ARCHITECT. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT'S 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); 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
    434568 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 170222 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR