BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HIV O PLUS

    MDR report key: 2000846 · Received February 24, 2011

    Report

    Report Number
    1415939-2011-00059
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 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). FA28MAR2011 WAS ISSUED FOR FALSELY ELEVATED REACTIVE RATES AND DECREASED SPECIFICITY FOR PRISM HIV O PLUS, LIST 3D34-48, LOT 94737HN00. THE INVESTIGATION HAS DETERMINED THAT THE US-DISTRIBUTED PRODUCT, LIST 3L68-68, 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 THIS LOT OF PRISM HIV O PLUS, LIST 3D34-48 REAGENT. THIS MANUFACTURING ISSUE AFFECTED NON-US PRODUCT ONLY, AS THIS ANTIGEN IS NOT USED IN THE US-DISTRIBUTED PRODUCT. EVALUATION: US PRODUCT NOT AFFECTED BY THIS ISSUE.

    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 3D34 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 3L68.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT FALSE POSITIVE PRISM (B)(6) O PLUS RESULTS WERE GENERATED. THE PATIENT WAS NEGATIVE WHEN TESTED WITH SIEMENS (B)(6). (B)(6). INITIAL RESULT: POSITIVE (2.01 S/CO) RETEST 1: POSITIVE (1.88 S/CO) RETEST 2: POSITIVE (2.06 S/CO) SIEMENS (B)(6): NEGATIVE (0.169) 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)