BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HTLV-I/HTLV-II

    MDR report key: 1900670 · Received November 16, 2010

    Report

    Report Number
    1415939-2010-00536
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MTP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, PRISM HTLV-I/HTLV-II, LIST NUMBER 6A53 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, PRISM HTLV-I/HTLV-II, LIST NUMBER 6E50. AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. THE EVALUATION BEGAN WITH A REVIEW OF THE TRACKING OF THE (B)(4) POPULATION FOR REAGENT LOT NUMBER 88652HN00 FOR DELTA VALUE, MEAN S/CO (SAMPLE/CUTOFF) AND MAXIMUM S/CO. NO RUN RULE VIOLATIONS OCCURRED INDICATING THAT THIS LOT IS NOT COMPROMISED REGARDING SPECIFICITY. TO EVALUATE THE SPECIFICITY PERFORMANCE OF THE REAGENT LOT A TOTAL OF EIGHT REPLICATES OF AN HTLV SPECIFICITY PANEL WERE ANALYZED ON BOTH SUB-CHANNELS. ALL GENERATED S/CO RESULTS FOR EACH INDIVIDUAL REPLICATE WERE WITHIN SPECIFICATIONS ((B)(4)) AND NO FALSE (B)(6) RESULTS WERE OBTAINED. TESTING WAS PERFORMED ON A RETAINED KIT OF PRISM HTLV-I/HTLV-II ASSAY KIT, LIST NUMBER 6A53-48, LOT NUMBER 88652HN00. ALL GENERATED DATA DEMONSTRATE THAT THE PERFORMANCE OF THE PRISM HTLV-I/HTLV-II ASSAY KIT, LIST NUMBER 6A53-48, LOT NUMBER 88652HN00 IS NOT COMPROMISED. 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 ABBOTT PRISM HTLV-I/HTLV-II REAGENT, LN 6A53-48 PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE CURRENT EVALUATION, IT WAS DETERMINED THAT THE PRISM HTLV-I/HTLV-II REAGENT, LIST NUMBER 6A53-48, LOT NUMBER 88652HN00, IS PERFORMING ACCEPTABLY. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A REACTIVE RESULT WITH THE PRISM HTLV-1/HTLV-2 ASSAY OF S/CO 1.40. THE SAMPLE WAS NON-REACTIVE UPON CONFIRMATORY TESTING. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. NO SPECIFIC INFORMATION WAS PROVIDED REGARDING THE SPECIMEN OR PATIENT. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM HTLV-I/HTLV-II FOR DETECTION OF HTLV-I/ HTLV-II ANTIBODIES IN HUMAN SERUM OR PLASMA MTP ABBOTT LABORATORIES 88652HN00

    Patients

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