BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 6130451 · Received November 28, 2016

    Report

    Report Number
    1415939-2016-00119
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    July 20, 2015
    Report Date
    May 18, 2017
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Product Problem
    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 U.S., LIST NUMBER 06D18. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(6).

    Additional Manufacturer Narrative · 1

    NO TESTING COULD BE PERFORMED WITH PRISM HCV REAGENT LOT 50561LI00 AS THIS LOT EXPIRED ON 30 NOVEMBER 2015. SAMPLE (B)(6) WAS RETURNED FROM THE CUSTOMER SITE AND TESTED WITH REAGENT LOT 68235LI00 (EXPIRATION DATE 20 MAY 2017). THE SAMPLE GENERATED A (B)(6), WHICH CORRELATED TO THE RESULTS RECEIVED BY THE CUSTOMER. FURTHER TESTING OF THIS RETURNED SAMPLE ON THE VIDAS AND DIASORIN LIASON PLATFORMS ALSO GENERATED (B)(6) RESULTS. THE MIKROGEN RECOMBLINE BLOT METHOD DETECTED THE BAND CORE 1 (+) AND THE RESULT WAS BORDERLINE. INNOLIA SCORE DETECTED THE BAND NS4 (3+) AND THE RESULT WAS INDETERMINATE. THESE RESULTS ARE IN ALIGNMENT WITH BLOT TESTING RESULT PERFORMED AT THE CUSTOMER SITE. SENSITIVITY TESTING WAS CARRIED OUT USING IN-HOUSE RETAINED, IN-DATE PRISM HCV REAGENT LOT 68235LI00. CALIBRATION PARAMETERS AND CONTROL RESULTS WERE WITHIN SPECIFICATIONS. FOUR REPLICATES OF FIVE MEMBERS OF A SENSITIVITY PANEL AS WELL AS THE POSITIVE RUN CONTROL WERE TESTED ON EACH SUBCHANNEL OF THE ABBOTT PRISM ANALYZER. ALL SPECIFICATIONS WERE MET WITH RESULTS IN THE TYPICAL RANGES SEEN FOR THESE SAMPLES. NO (B)(6) RESULTS WERE GENERATED. CLINICAL SENSITIVITY WAS ALSO EVALUATED WITH TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS. ALL SPECIFICATIONS WERE MET, INDICATING THAT THE SENSITIVITY PERFORMANCE IS NOT ADVERSELY AFFECTED. NO ISSUES WERE DETERMINED TO EXIST FOR REAGENT LOT 68235LI00. THE ABBOTT PRISM ANALYZER, LIST 06A36-10, SERIAL NUMBER (B)(4), WAS ALSO INVESTIGATED AND FOUND TO BE PERFORMING ACCEPTABLY. 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 NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED FOR THE AFFECTED LOT. 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. ON (B)(6) 2016, (B)(6) RESULTS RECEIVED FOR (B)(6) QUESTIONABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON NOVEMBER 8, 2016 ABBOTT LABORATORIES (B)(4) RECEIVED AN INITIAL REPORT SENT BY THE NATIONAL BLOOD BANK OF (B)(6) (VADC) REGARDING A POTENTIALLY (B)(6) RESULT. PRISM HCV REAGENT LOT 50561LI00 WAS IN USE AT THE TIME. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) GENERATED (B)(6) RESULTS ((B)(6)) WHEN INITIALLY TESTED ON (B)(6) 2016 ON THE ROCHE COBAS ANALYZER. THE SAMPLE WAS SENT TO (B)(6) FOR CONFIRMATORY TESTING AND GENERATED THE FOLLOWING RESULTS: (B)(6) CORE AG: (B)(6) AND IMMUNOBLOT: (B)(6). NO BLOOD PRODUCTS WERE RELEASED FROM THIS DONATION. DURING A RETROSPECTIVE INVESTIGATION PERFORMED BY VADC, ARCHIVED (B)(6) OF THIS AFFECTED BLOOD DONOR WAS PULLED AND RETESTED ON THE ROCHE COBAS ANALYZER ON (B)(6) 2016, WHICH ALSO GENERATED (B)(6) RESULT ((B)(6)). THIS SAMPLE GENERATED NEGATIVE RESULTS WHEN TESTED WITH THE ABBOTT PRISM HCV ASSAY (REAGENT LOT 50561LI00) AND THE NAT SYSTEM ON (B)(6) 2015. BLOOD PRODUCTS FROM THIS DONATION WERE NOT RELEASED FOR USE TO HEALTH CARE PROVIDERS. ON (B)(6) 2016, (B)(6) WAS SENT TO (B)(6) FOR CONFIRMATORY TESTING RESULTS OF WHICH ARE PENDING. THE DATA IS ASSOCIATED WITH THE TESTING OF ARCHIVED SAMPLES. SAMPLES THAT ORIGINALLY TESTED NEGATIVE BY PRISM WERE STORED. THE SAMPLES HAVE SUBSEQUENTLY BEEN PULLED AND TESTED BY VADC USING ROCHE AND BY (B)(6) USING VARIOUS ALTERNATE (B)(6) METHODS, INCLUDING ARCHITECT. THIS TESTING IS BEING PERFORMED AS PART OF A STUDY BY VADC DUE TO PERFORMANCE DIFFERENCES THEY ARE EXPERIENCING BETWEEN ROCHE (CURRENT METHOD) AND PRISM (PAST METHOD) FOR (B)(6). NONE OF THE RESULTS, WHETHER BY VADC ROCHE TESTING OR (B)(6) ARCHITECT TESTING, ARE BEING USED FOR DONOR MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779487 PRISM HCV ANTI-HCV MZO ABBOTT LABORATORIES 50561LI00

    Patients

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