BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HIV O PLUS

    MDR report key: 2000795 · Received February 24, 2011

    Report

    Report Number
    1415939-2011-00058
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FA (B)(6) 2011 WAS ISSUED FOR FALSELY ELEVATED REACTIVE RATES AND DECREASED SPECIFICITY FOR PRISM (B)(6), LIST (B)(4), LOTS 94737HN00 AND 96484HN00. THE INVESTIGATION HAS DETERMINED THAT THE US-DISTRIBUTED PRODUCT, LIST (B)(4), IS NOT AFFECTED BY THIS ISSUE AND IS NOT WITHIN THE SCOPE OF THIS ACTION. THE CAUSATIVE AGENT WAS DETERMINED TO BE A SPECIFIC LOT OF ANTIGEN USED TO MANUFACTURE THE P41 PROBE USED IN THESE TWO LOTS OF PRISM HIV O PLUS, LIST (B)(4) REAGENT. THIS MANUFACTURING ISSUE AFFECTED NON-US PRODUCT ONLY, AS THIS ANTIGEN IS NOT USED IN THE US-DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT FALSE (B)(6) PRISM HIV O PLUS RESULTS WERE GENERATED. THE PATIENT WAS (B)(6) WHEN TESTED WITH SIEMENS ENZYGNOST HIV INTEGRAL II. PRISM HIV GROUP O PLUS: INITIAL RESULT: (B)(6), RETEST 1: (B)(6), RETEST 2: (B)(6). SIEMENS ENZYGNOST HIV INTEGRAL II: (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM HIV O PLUS FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES MZF ABBOTT LABORATORIES 94737HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ABBOTT PRISM ANALYZER 6A36-04 SN (B)(4)| ABBOTT PRISM ANALYZER 6A36-04 SN (B)(4)