BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 3864006 · Received June 10, 2014

    Report

    Report Number
    1823260-2014-04218
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). DEVICE SUBASSEMBLY = RINSE STATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR APPROXIMATELY 10 PATIENT SAMPLES TESTED FOR ALBUMIN. OF THE AFFECTED PATIENT SAMPLES, THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE THAT HAD AN ERRONEOUS RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 51.7 G/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR CALLED AND QUESTIONED THE INITIAL VALUE, SO THE SAMPLE WAS REPEATED. THE SAMPLE REPEATED AS EITHER 30 G/L OR 30.3 G/L ON (B)(6) 2014. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ALBUMIN REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. IT WAS OBSERVED BY A SERVICE REPRESENTATIVE THAT THE SAMPLE PROBE 1 WAS MISALIGNED AND NEARLY HITTING THE CUVETTE COVER. THE REPRESENTATIVE RAN A PRECISION CHECK FOR ALBUMIN. THE FIELD SERVICE ENGINEER DETERMINED THAT THE SAMPLE PROBE A WAS CLOSE TO THE EDGE OF THE CUVETTE GUARD. HE REALIGNED THE PROBE. HE FOUND THAT THE CUVETTES WERE COVERED IN DUST FROM THE RINSE HEAD COVERS. HE REMOVED THE COVERS AND THEY WERE CLEANED AND ADJUSTED. HE DETERMINED THAT THE R2/3A RINSE STATION PRESSURE WAS LOW. HE ADJUSTED THE GEAR HEAD PRESSURE AND RINSE STATION PRESSURE. HE DETERMINED THAT THE TUBING ON RINSE HEAD 3 WAS IN POOR CONDITION AND THERE WAS A HOLE IN THE #4 VACUUM LINE. HE REPLACED ALL TUBING ON THE RINSE HEAD. HE RAN PRECISION CHECKS FOR REAGENT A AND B. PRECISION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340983 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR