BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRONOSTIKA HIV-1 MICROELISA SYSTEM

    MDR report key: 801227 · Received December 21, 2006

    Report

    Report Number
    3002769706-2006-00005
    Event Type
    Malfunction
    Date Received
    December 21, 2006
    Date of Event
    November 2, 2006
    Report Date
    December 15, 2006
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MTP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMERIEUX INC. IS INITIATING A VOLUNTARY RECALL OF THE VIRONOSTIKA HIV- MICROELISA SYSTEM (PRODUCT # 259605, 259717) FOR THE LOT NOTED ABOVE. THIS RECALL IS BEING CONDUCTED AS A RESULT OF AN INTERNAL QUALITY INVESTIGATION IN WHICH WE WERE ABLE TO CONFIRM ONE CUSTOMER COMPLAINT OF NO REACTIVITY ON A SINGLE COATED PLATE FROM THIS LOT. WE BELIEVE THAT THIS COMPLAINT MAY BE AN ISOLATED INCIDENT, HOWEVER, WE CANNOT DETERMINE THIS WITH CERTAINTY, THEREFORE WE ARE RECALLING THIS LOT. UNDER MOST CONDITIONS OF USE, A NON-REACTIVE STRIP WOULD BE DETECTED BY THE KIT'S POSITIVE CONTROL. HOWEVER, THE POTENTIAL FOR FALSE NEGATIVE RESULTS DOES EXIST IF A CUSTOMER COMBINES STRIP WELLS FROM A REACTIVE PLATE WITH STRIP WELLS FROM AN AFFECTED NON-REACTIVE PLATE. THIS COMBINATION WOULD RESULT IN A VALID RUN IF THE KIT CONTROLS WERE TESTED ON THE REACTIVE STRIP. TESTING OF ADDITIONAL KITS FROM SAME CUSTOMER AND RETAINS DID NOT DUPLICATE PROBLEM. THE QUALITY ASSURANCE DEPARTMENT AT THE BIOMERIEUX DURHAM HAS ISSUED A CAPA # 1359 TO CONTINUE THE INVESTIGATION TO CLEARLY IDENTIFY ROOT CAUSE AND IMPLEMENT PREVENTIVE ACTION. UPON DETERMINATION OF A ROOT CAUSE, PREVENTIVE ACTION WILL BE IMPLEMENTED WITHIN THE APPLICABLE IDENTIFIED PROCESSES PER THE CAPA PROCESS.

    Description of Event or Problem · 1

    THE INITIAL COMPLAINT WAS THAT, THE CUSTOMER IS SEEING NO REACTIVITY ON 1 OF 2 PLATES IN 192T KIT LOT #160354. QC IMMUNODIAGNOSTICS WAS ABLE TO CONFIRM THIS CUSTOMER COMPLAINT OF NO REACTIVITY AND DETERMINE THE DEFECT TO BE ISOLATED TO THE COATED PLATES STRIPS. FOLLOWING A COMPREHENSIVE DATA REVIEW OF CUSTOMER AND QC IMMUNODIAGNOSTICS GENERATED DATA, IT WAS DETERMINED THAT THE CUSTOMER PLATE WAS NON-REACTIVE. WITHIN TYPICAL LAB PRACTICES, THIS SHOULD HAVE BEEN IDENTIFIED THROUGH THE USE OF THE POSITIVE CONTROL. IT SHOULD ALSO BE NOTED THAT PATIENT RESULTS WERE NOT REPORTED FROM THIS ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRONOSTIKA HIV-1 MICROELISA SYSTEM HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 MTP BIOMERIEUX, INC. 259605/25717 160354

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention