BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HTLV-I/HTLV-II

    MDR report key: 2963327 · Received February 15, 2013

    Report

    Report Number
    1415939-2013-00058
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MTP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETAINED KIT OF PRISM HTLV-1 / HTLV-2 REAGENT, LIST NUMBER 06A53-48 LOT NUMBER 21105LI00 WAS CALIBRATED ON ONE PRISM ANALYZER. TO EVALUATE THE PERFORMANCE WITH REGARD TO SPECIFICITY, REPLICATES OF AN HTLV-1 / HTLV-2 SPECIFICITY PANEL WERE TESTED. RESULTS WERE WITHIN TYPICAL RANGES AND NO FALSE REACTIVE RESULTS WERE OBTAINED. A REVIEW OF THE HUMAN NEGATIVE POPULATION, ROUTINELY EVALUATED DURING RELEASE TESTING, REVEALED NO INDICATIONS THAT THE SPECIFICITY OF THE REAGENT LOT MIGHT BE ADVERSELY AFFECTED. THE MEAN VALUE ACROSS ALL PANEL MEMBERS FOR THIS LOT NUMBER CORRESPONDS TO THE MEAN OBSERVED FOR ALL LOT NUMBERS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. ADDITIONALLY, THE PERFORMANCE WAS INVESTIGATED BY COMPLETING A REVIEW OF MANUFACTURING AND TESTING RECORDS FOR THE AFFECTED REAGENT LOT. THIS REVIEW DID NOT REVEAL ANY EVENTS OR ISSUES THAT MAY HAVE IMPACTED REAGENT PERFORMANCE IN RELATION TO THE CURRENT COMPLAINT ISSUE. THE PRISM HTLV-1/HTLV-2 ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION, IT HAS BEEN DETERMINED THAT THE PRISM HTLV-1 / HTLV-2 REAGENT, LIST NUMBER 06A53-48, LOT NUMBER 21105LI00, IS PERFORMING ACCEPTABLY.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06A53 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06E50. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS AN INCREASE IN REPEAT (B)(6) RATES FOR THE PRISM HTLV-I/HTLV-II ASSAY WHEN THEY SWITCHED TO REAGENT LOT 21105LI00. THIS OCCURRED DURING THE TIMEFRAME OF (B)(6)2013. THIS HAS RESULTED IN DONORS WHO PREVIOUSLY TESTED (B)(6) TO NOW TEST (B)(6). THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLE: DONOR 8: INITIAL (B)(6) RESULT OF (B)(6); REPEAT (B)(6) RESULTS OF (B)(6). PREVIOUS (B)(6) RESULT OF (B)(6) ON (B)(6) 2012 WITH REAGENT LOT 16437LI00. TO DATE, THE CUSTOMER HAS SEEN THEIR REPEAT (B)(6) RATE RISE TO 0.05%. THERE IS NO FURTHER IMPACT TO DONOR MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69287 PRISM HTLV-I/HTLV-II MTP ABBOTT LABORATORIES 21105LI00

    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)