BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 6503443 · Received April 19, 2017

    Report

    Report Number
    1823260-2017-00820
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    March 31, 2017
    Report Date
    May 17, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE CONFIRMED THAT THE OBSERVED DETERGENT CRYSTALLIZATION ON THE CUVETTE SEGMENTS CAN INFLUENCE THE BUN ASSAY, CAUSING LOWER VALUES TO BE GENERATED. THE CRYSTALS MAY MOVE FROM THE EDGE OF THE CUVETTE SEGMENT INTO THE FIRST OR LAST CUVETTE OF THAT SEGMENT. AN IMPACT MAY BE DETECTABLE FOR OTHER TESTS, BUT BUN IS HIGHLY SUSCEPTIBLE TO SUCH CRYSTALLIZATION. IT WAS RECOMMENDED TO THE CUSTOMER TO REMOVE THE CUVETTES COMPLETELY, CLEAN THE WATER BATH THOROUGHLY, INSTALL NEW CUVETTES, AND VERIFY PROBE ADJUSTMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAVE BEEN HAVING ISSUES WITH INFREQUENT QUESTIONABLE LOW RESULTS FOR UREAL UREA/BUN (BUN) ON TWO COBAS 8000 C 702 MODULES (C702). AS PART OF TROUBLESHOOTING FOR THESE ISSUES IN THE PAST, IT WAS DETERMINED THAT A POSSIBLE CAUSE WAS LABORATORY HUMIDITY. IT WAS RECOMMENDED TO THE CUSTOMER AT THAT TIME TO USE A HUMIDIFIER IN THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE SECOND AFFECTED C702 ANALYZER. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FIRST AFFECTED C702 ANALYZER. THE CUSTOMER STATES THAT THE ISSUE HAS NOW RETURNED STARTING ON (B)(6) 2017. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENT SAMPLE THAT HAD QUESTIONABLE BUN RESULTS. OF THESE FOUR SAMPLES, ONE HAD AN ERRONEOUS BUN RESULT. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 5.6 MMOL/L AND WHEN REPEATED, IT RESULTED AS 23.5 MMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE BUN REAGENT LOT NUMBER WAS 212533. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE PRE-ANALYTIC SAMPLE HANDLING CONDITIONS OF THE LABORATORY AND EVERYTHING WAS OK. THE SYSTEM WAS CHECKED AND IT WAS DETERMINED THAT THE CUVETTES WERE IN USE FOR 1.5 MONTHS. CRYSTALLIZATION WAS OBSERVED AT THE INTERFACE OF CUVETTE SEGMENTS. THE CUVETTES AND SAMPLE PROBES WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285707 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1