BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HIV O PLUS

    MDR report key: 2495077 · Received March 18, 2012

    Report

    Report Number
    1415939-2012-00075
    Event Type
    Malfunction
    Date Received
    March 18, 2012
    Date of Event
    January 23, 2012
    Report Date
    March 15, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINTS RECEIVED TO-DATE WERE REVIEWED TO DETERMINE IF OTHER CUSTOMERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THIS FACILITY. THE REVIEW OF THIS DATA DID NOT IDENTIFY ANY ADVERSE TREND IN REPORTS RELATED TO THE ISSUE THAT WOULD SUGGEST A POTENTIAL PROBLEM. CLINICAL SPECIFICITY WAS EVALUATED BY COMPLETING A REVIEW OF FIELD DATA REPORTED TO THE ABBOTT PRISM METRICS DATABASE FROM CUSTOMERS USING THE PRISM HIV O PLUS ASSAY. (B)(4). A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE PRISM HIV O PLUS PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THIS PRESENT INVESTIGATION, THE ABBOTT PRISM HIV O PLUS REAGENTS, LIST NUMBER 03L68 ARE PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    ONE PATIENT GENERATED A FALSE POSITIVE (REPEAT REACTIVE) RESULT WITH THE PRISM HIV O PLUS ASSAY THAT GENERATED A NEGATIVE WESTERN BLOT RESULT. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM HIV O PLUS MZF ABBOTT LABORATORIES 10329M501

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL-CE LN: 06A36-04 SN: (B)(4)| PRISM 6 CHANNEL-CE LN: 06A36-04 SN: (B)(4)