BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 6506934 · Received April 20, 2017

    Report

    Report Number
    1823260-2017-00827
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    April 1, 2017
    Report Date
    April 20, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED QUESTIONABLE RESULTS FOR 23 PATIENT URINE SAMPLES USING THE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON THE COBAS 8000 C 502 MODULE (C502). TWO EXAMPLES ARE PROVIDED BELOW. PLEASE SEE THE ATTACHMENT FOR ADDITIONAL PATIENT RESULTS. ALL RESULTS ARE PROVIDED IN UNITS OF G/L. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT FOR PATIENT A WAS 1.586. THE DOCTOR SENT THE PATIENT TO THE EMERGENCY UNIT FOR RETESTING. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 0.099. THE INITIAL RESULT FOR PATIENT B (FEMALE, AGE (B)(6)) WAS 1.202. THE DOCTOR SENT THE PATIENT TO THE EMERGENCY UNIT FOR RETESTING. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 0.067. THE LABORATORY STAFF PERFORMED REPEAT TESTING ON OTHER PATIENT SAMPLES FROM (B)(6) 2017 AFTER THE EVENTS WITH PATIENT A AND B, AND DISCOVERED THE ADDITIONAL 21 QUESTIONABLE RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT FOR ANY OF THE PATIENTS. THE TPUC3 REAGENT LOT NUMBER IS 223039. EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. CALIBRATION AND QC WERE ACCEPTABLE ON THE DATE OF THE EVENT. THE CUSTOMER COMPLETED A PRECISION CHECK ON TPUC3 WHICH WAS BAD. THE FIELD SERVICE REPRESENTATIVE INSPECTED THE INSTRUMENT AND FOUND A CLOGGED NOZZLE IN THE RINSE STATION. HE DECONTAMINATED THE RINSE NOZZLE AND ACCEPTABLE PERFORMANCE WAS CONFIRMED AFTER SERVICE. THE SPECIFIC ROOT CAUSE FOR THIS ISSUE WAS THE CONTAMINATION OF THE RINSE NOZZLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290379 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C502 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR