BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 4162128 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07785
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. IT WAS OBSERVED THAT THE EXTERNAL WATER RESERVOIR HAD JUST BEEN FILLED ON THE INSTRUMENT AND IT IS POSSIBLE THAT THE SYSTEM MAY NOT HAVE BEEN PRIMED PRIOR TO RUNNING SAMPLES. IF THE SYSTEM IS NOT PRIMED, IT MAY BE POSSIBLE TO HAVE AIR WITHIN IT. THE FACT THAT NO ADDITIONAL EVENTS WERE REPORTED AFTER THE SERVICE VISIT SUPPORTS THE POSSIBILITY THAT THE SYSTEM WAS NOT PRIMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD QUESTIONABLE RESULTS FOR MULTIPLE ANALYTES TESTED FOR ONE PATIENT SAMPLE. THE CUSTOMER REPEATED SOME OF THE TESTS AND THEN DECIDED TO SEND THE SAMPLE TO THE HOSPITAL FOR CONFIRMATION. IT WAS DETERMINED THAT THERE WERE ERRONEOUS RESULTS FOR CALCIUM GEN.2 (CALCIUM), TOTAL PROTEIN GEN.2 MONOCHROMATIC (TOTAL PROTEIN), AND ISE POTASSIUM. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS FROM THE HOSPITAL WERE BELIEVED TO BE CORRECT. NO ERRORS WERE ISSUED BY THE ANALYZER. THE CUSTOMER CHECKED OTHER RESULTS FOR THE DAY, BUT DID NOT FIND ANY OTHER DISCREPANCIES. THE SAMPLE INITIALLY RESULTED AS 2.3 MG/DL FOR CALCIUM, 2.4 G/DL FOR TOTAL PROTEIN, AND 4.8 MMOL/L FOR ISE POTASSIUM. THE SAMPLE WAS REPEATED AT THE HOSPITAL, RESULTING AS 10.2 MG/DL FOR CALCIUM, 7.3 G/DL FOR TOTAL PROTEIN, AND 5.5 MMOL/L FOR ISE POTASSIUM. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT NUMBER WAS 69856001 WITH AN EXPIRATION DATE OF 07/31/2015. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 69725401 WITH AN EXPIRATION DATE OF 06/30/2015. THE LOT NUMBER AND EXPIRATION DATE FOR THE ISE POTASSIUM ELECTRODE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS AIR IN THE SAMPLE PROBE TUBING. HE REPLACED THE SAMPLE PROBE AND TUBING. HE CHECKED THE SYRINGE TIP AND WATER RESERVOIR TUBINGS. HE RAN A CHECK TEST IN ORDER TO CHECK PRECISION AND THIS PASSED. THE CUSTOMER CHECKED CALIBRATOR AND CONTROL VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644876 COBAS C111 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR