BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 4000 C (311) STAND ALONE SYSTEM

    MDR report key: 6453933 · Received April 3, 2017

    Report

    Report Number
    1823260-2017-00698
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 15, 2017
    Report Date
    April 3, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT URINE SAMPLE TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (MALB) AND CREJ2 CREATININE JAFFÉ GEN.2 (CREJ) ON A COBAS 4000 C (311) STAND ALONE SYSTEM - C311. OF THE MENTIONED TESTS, THE SAMPLE HAD AN ERRONEOUS RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY FOR MALB. THE SAMPLE INITIALLY RESULTED AS 341.6 MG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS 51.8 MG/L. THE 51.8 MG/L VALUE WAS ALSO REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS ALSO REPEATED ON (B)(6) 2017, RESULTING AS 52.5 MG/L. AN AMENDED REPORT WAS ISSUED FOR THE FINAL RESULT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE MALB REAGENT LOT NUMBER WAS 155919. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THAT THE SAMPLE PROBE WAS DIRTY. THE ENGINEER ALSO NOTED THAT HE CUSTOMER WAS RUNNING SAMPLES IN CUPS PLACED ON TOP OF TUBES. THE ENGINEER CLEANED THE SAMPLE PROBE INTERNALLY AND EXTERNALLY. THE ENGINEER CLEANED THE WASH STATION AND DRYING CYLINDER. THE ENGINEER VERIFIED THAT SPECIAL WASHES WERE INSTALLED AS RECOMMENDED. THE ENGINEER RAN CONTROLS IN CUPS AND THESE RECOVERED WITHIN RANGE. UPON REVIEW OF CALIBRATION AND CONTROL DATA, IT WAS NOTED THAT MANY CALIBRATIONS WERE FLAGGED WITH ERRORS AND CONTROLS WERE OFTEN OUTSIDE OF RANGE HIGH. ON THE DATE OF THE EVENT, A CONTROL LEVEL WAS WITHIN RANGE AT 14:18 AND HIGH AT 14:51. THE CONTROL RECOVERY SHOWED THAT THERE WAS SOMETHING WRONG WITH THE SYSTEM. THE SAMPLE PROBE WAS DIRTY. RESULTS FOR OTHER TESTS WERE FLAGGED, INDICATING THAT THE REAGENTS WERE EXPIRED. IMPROPER MAINTENANCE WAS CARRIED OUT ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234920 COBAS 4000 C (311) STAND ALONE SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR