BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7580219 · Received June 7, 2018

    Report

    Report Number
    1221359-2018-00319
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    September 27, 2016
    Report Date
    June 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING WAS PERFORMED ON RETAINED KIT LOT 160417 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 160417 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. MANUFACTURING BATCH RECORDS FOR LOT 160707 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CUSTOMER RETURNED THE SOURCE PATIENT SAMPLE AND IT WAS TESTED WITH RETAIN DEVICES OF THE SAME KIT LOT AND A NEW LOT (160707). THE (B)(6) 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 (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBER 160417 AND 160707 SHOWED THAT THE COMPLAINT RATES 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 CUSTOMER REPORTS AN EMPLOYEE WAS EXPOSED TO BLOOD PRODUCTS FROM A SOURCE PATIENT WITH A (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO TEST RESULT. THE EMPLOYEE WHO HAD THE (NEEDLESTICK) EXPOSURE WAS NOT REPORTED TO HAVE BEEN TESTED WITH ALERE DETERMINE HIV 1/2 AG/AB COMBO. IT IS UNKNOWN IF THE EMPLOYEE RECEIVED ANY MEDICAL INTERVENTION AS A RESULT OF THE EXPOSURE. THE EMPLOYEE GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. A (B)(6) AG RESULT WAS REPORTED ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO FROM A MALE (SOURCE) PATIENT FOR A NEEDLESTICK EXPOSURE. THE TEST WAS REPEATED AND THE SAME RESULT WAS OBTAINED. THE SAMPLE WAS REPEATED ON LOT 160707 AND THE SAME RESULT WAS OBTAINED. THE (SOURCE) PATIENT WAS CONFIRMED (B)(6) BY ARCHITECT AND VIRAL LOAD ((B)(6)). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT 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)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421833 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 160417 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1