BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISM HCV

    MDR report key: 6184034 · Received December 17, 2016

    Report

    Report Number
    1415939-2016-00122
    Event Type
    Injury
    Date Received
    December 17, 2016
    Date of Event
    May 9, 2013
    Report Date
    May 19, 2017
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06A52, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06D18. PATIENT ID: (B)(6) NO TESTING COULD BE PERFORMED AS THE PRISM HCV REAGENT LOT IN QUESTION HAS EXPIRED. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO ADDITIONAL ISSUES WERE IDENTIFIED. NO RELATED ADVERSE OR NON-STATISTICAL TRENDS WERE NOTED FOR THIS REAGENT LOT. ALSO, NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. THE ABBOTT PRISM ANALYZER, LIST 06A36-10, SERIAL NUMBER (B)(4), WAS ALSO INVESTIGATED AND FOUND TO BE PERFORMING ACCEPTABLY. THE ABBOTT PRISM HCV ASSAY PACKAGE INSERT AS WELL AS THE ABBOTT PRISM OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT RECEIVED NOTIFICATION THAT THE (B)(6) NOTIFIED THEIR COMPETENT AUTHORITY OF AN ISSUE REGARDING ALLEGED (B)(6) RESULTS FOR DONOR UNITS. THIS WAS A RETROSPECTIVE REPORT SUBMITTED BY (B)(6) AFTER THE PRISM ANALYZER WAS UNINSTALLED FROM THAT SITE AND REPLACED WITH THE ROCHE COBAS SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED: SAMPLE (B)(6): ON (B)(6) 2016, SAMPLE TESTED ON THE ROCHE COBAS ANALYZER AND GENERATED (B)(6) COI RESULTS OF (B)(6). THE SAMPLE WAS THEN SENT TO THE (B)(6) FOR CONFIRMATORY TESTING WHERE THE SAMPLE GENERATED (B)(6) RESULTS FOR (B)(6) CORE ANTIGEN AND IMMUNOBLOT RESULTS OF C1 1+ (INDETERMINATE). NO BLOOD PRODUCTS FROM THIS DONATION WERE USED FOR MEDICAL TREATMENT. (B)(6) THEN PULLED AN ARCHIVED SAMPLE FROM THIS SAME DONOR (B)(6) THAT WAS ORIGINALLY TESTED ON (B)(6) 2013 WITH PRISM HCV ASSAY LOT 28560LI00. THIS SAMPLE GENERATED (B)(6) RESULTS WITH THE PRISM HCV ASSAY AS WELL AS WITH THE NAT METHODOLOGY. ON (B)(6) 2016, THIS SAMPLE GENERATED (B)(6) RESULTS OF (B)(6) ON THE ROCHE COBAS PLATFORM. RED BLOOD CELLS, CRYOPRECIPITATE AND PLATELETS WERE DISTRIBUTED FOR MEDICAL USE FROM THIS DONATION. CONFIRMATORY TESTING RESULTS WITH THE IMMUNOBLOT PLATFORM WERE C1 1+ QUESTIONABLE. THIS DATA IS ASSOCIATED WITH THE TESTING OF ARCHIVED SAMPLES. SAMPLES THAT ORIGINALLY TESTED (B)(6) BY PRISM WERE STORED. THE SAMPLES HAVE SUBSEQUENTLY BEEN PULLED AND TESTED BY (B)(6) USING ROCHE AND BY (B)(6) USING VARIOUS ALTERNATE HCV METHODS, INCLUDING ARCHITECT. THIS TESTING IS BEING PERFORMED AS PART OF A STUDY BY (B)(6) DUE TO PERFORMANCE DIFFERENCES THEY ARE EXPERIENCING BETWEEN ROCHE (CURRENT METHOD) AND PRISM (PAST METHOD) FOR (B)(6). NONE OF THE RESULTS, WHETHER BY (B)(6) (ROCHE TESTING) OR (B)(6) (ARCHITECT TESTING) ARE BEING USED FOR DONOR MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834887 PRISM HCV ANTI-HCV MZO ABBOTT LABORATORIES 28560LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ABBOTT PRISM 4 CHAN LN: 06A36-10| SN: (B)(4)