BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ¿-CROSSLAPS/SERUM IMMUNOASSAY

    MDR report key: 9152004 · Received October 3, 2019

    Report

    Report Number
    1823260-2019-03556
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    May 31, 2019
    Report Date
    February 4, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMM
    PMA / PMN Number
    K993706
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE QC DATA PROVIDED FROM THE E801 MODULE WAS ACCEPTABLE. A SAMPLE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE CUSTOMER¿S RESULTS. A HETEROPHILIC INTERFERENCE WAS FOUND IN THE SAMPLE. THE INTERFERENCE IS DESCRIBED IN THE PRODUCT LABELING: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER PERFORMED A NEUTRALIZATION PROCEDURE ON THE PATIENT SAMPLE IN AN ATTEMPT TO ELIMINATE THE INTERFERENCE WITH NO SUCCESS.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS B-CROSSLAPS/SERUM (B-CROSSLAPS) ON A COBAS E 801 MODULE COMPARED TO A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL RESULT FROM THE E801 MODULE WAS > 6000 PG/ML. SINCE THIS RESULT DID NOT CORRESPOND TO THE PATIENT'S CLINICAL PICTURE, A NEW SAMPLE WAS REQUESTED. ON (B)(6) 2019 A NEW SAMPLE WAS OBTAINED AND THE RESULT ON THE E801 MODULE WAS 5598 PG/ML. THIS SAMPLE WAS REPEATED ON AN E411 ANALYZER IN A DIFFERENT LABORATORY AND THE RESULT WAS 389.4 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER SUSPECTS AN INTERFERENCE OF THE PATIENT SAMPLE AND THE E801 MODULE METHODOLOGY. THE E801 MODULE SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948320 ELECSYS ¿-CROSSLAPS/SERUM IMMUNOASSAY COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE JMM ROCHE DIAGNOSTICS NA 349942

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR