BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HIV O PLUS

    MDR report key: 4956629 · Received July 31, 2015

    Report

    Report Number
    1415939-2015-00029
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    March 9, 2016
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION SHOULD HAVE INDICATED THAT A DEFICIENCY WAS NOT IDENTIFIED, AS FOLLOWS: FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF PRODUCT LABELING AND A SEARCH FOR SIMILAR COMPLAINTS. THE CUSTOMER INITIAL REACTIVE (IR) AND REPEAT REACTIVE (RR) RATES WERE REVIEWED AND IT WAS DETERMINED THAT BOTH THE IR AND RR RATES ARE WITHIN LABEL CLAIM FOR LOT 49500M500. DUE TO AN INCREASE IN COMPLAINT ACTIVITY FOR THIS ISSUE A DEFICIENCY HAS NOT BEEN IDENTIFIED FOR ABBOTT PRISM HIV O PLUS, LIST NUMBER 3L68, LOT 49500M500.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE IN QUESTION WAS CHANGED FROM THE PRISM 6 CHANNEL ANALYZER, LIST NUMBER 06A36-04, TO THE PRISM HIV O PLUS ASSAY, LIST NUMBER 03L68-68. THIS CHANGES THE MANUFACTURING LOCATION. THE EVENT WAS INITIALLY DOCUMENTED UNDER MDR 1628664-2015-00175. ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THIS MDR NUMBER. FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF PRODUCT LABELING AND A SEARCH FOR SIMILAR COMPLAINTS. THE CUSTOMER (B)(6) RATES WERE REVIEWED AND IT WAS DETERMINED THAT BOTH THE (B)(6) RATES ARE WITHIN LABEL CLAIM FOR LOT 49500M500. DUE TO AN INCREASE IN COMPLAINT ACTIVITY FOR THIS ISSUE, A DEFICIENCY HAS BEEN IDENTIFIED FOR ABBOTT PRISM HIV O PLUS, LIST NUMBER 3L68, LOT 49500M500.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE PRISM HIV O PLUS ASSAY. THE CUSTOMER INDICATED THAT MULTIPLE PATIENT SPECIMENS WHICH WERE BOTH INITIAL AND REPEAT (B)(6) USING THE PRISM HIV O PLUS ASSAY, WERE (B)(6) WHEN TESTED USING THE (B)(6) METHOD. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502039 PRISM HIV O PLUS HIV-1 AND HIV-2 ANTIBODIES MZF ABBOTT LABORATORIES 49500M500

    Patients

    Seq Age Sex Outcome Treatment
    1