BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIVAB HIV-1/HIV-2 (RDNA) EIA

    MDR report key: 1022522 · Received March 24, 2008

    Report

    Report Number
    1628664-2008-00076
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LRM
    PMA / PMN Number
    K897158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT DATE RECEIVED BY MANUFACTURER ON THE INITIAL REPORT WAS LISTED AS (B)(6) 2006 WAS INCORRECT. THE CORRECT DATE RECEIVED BY MANUFACTURER ON THE INITIAL REPORT SHOULD BE LISTED AS (B)(6) 2008. EVALUATION LISTED AS NA DUE TO FOLLOW-UP REPORT TO CORRECT INFORMATION FOR INITIAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED AN INCREASED HIV-1/2 EIA REACTIVE RATE PROCESSED ON THE COMMANDER PPC THAT DID NOT CONFIRM POSITIVE. THE ACCOUNT STATED A TOTAL OF 8 SPECIMENS TESTED HIV-1/2 EIA REACTIVE BUT NUCLEIC ACID TESTING (NAT), WESTERN BLOT AND HIV-2 NEGATIVE. THE FIELD SERVICE ENGINEER WAS REQUESTED FOR THE COMMANDER PPC FOR POSSIBLE SYSTEM CONTAMINATION. AFTER SERVICE WAS RECEIVED ON THE COMMANDER PPC, ONE MORE PATIENT TESTED HIV-1/2 EIA REPEATEDLY REACTIVE BUT NAT, WESTERN BLOT AND HIV-2 NEGATIVE. NO SPECIFIC PATIENT DATA IS AVAILABLE. MOST OF THE REACTIVE HIV-1/2 EIA RESULTS WERE GENERATED FROM HIGH SCHOOL STUDENTS. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIVAB HIV-1/HIV-2 (RDNA) EIA IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES LRM ABBOTT LABORATORIES NA 59024M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT 59024M200| PPC LIST 6208-01, (B)(4)| HIVAB HIV-1/HIV-2 (RDNA) LIST 3A77-78| LOT 59196M100