BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1914343 · Received December 3, 2010

    Report

    Report Number
    1823260-2010-07152
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED ERRATIC QUESTIONABLE RESULTS FOR VARIOUS ASSAYS FOLLOWING THE DETECTION OF A CLOT IN A SAMPLE EARLIER IN THE DAY. THE USER PROVIDED DATA FOR FOUR PATIENT SAMPLES, OF WHICH THE RESULTS FOR THREE PATIENT SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL BICARBONATE LIQUID (BICARBONATE) RESULT WAS 15 MMOL/L AND THE REPEAT RESULT WAS 28 MMOL/L. THE INITIAL CALCIUM RESULT WAS 1.8 MMOL/L AND THE REPEAT RESULT WAS 2.4 MMOL/L. THE INITIAL TOTAL PROTEIN GENERATION 2 (TOTAL PROTEIN) RESULT WAS 0.1 G/DL AND THE REPEAT RESULT WAS 7.6 G/DL. THE INITIAL ALBUMIN 2 (ALBUMIN) RESULT WAS 0.9 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. THE INITIAL GLUCOSE HK GENERATION 3 (GLUCOSE) RESULT WAS 0 MG/DL AND THE REPEAT RESULTS WERE 78 AND 90 MG/DL. PATIENT SAMPLE 2 WAS FROM AN (B)(6) FEMALE. THE INITIAL TOTAL PROTEIN RESULT WAS 0.0 G/DL AND THE REPEAT RESULTS WERE 5.8 AND 5.9 G/DL. PATIENT SAMPLE 3 WAS FROM AN (B)(6) FEMALE. THE INITIAL BICARBONATE RESULT WAS 0 MMOL/L AND THE REPEAT RESULT WAS 24 MMOL/L. THE INITIAL GLUCOSE RESULT WAS 58 MG/DL AND THE REPEAT RESULT WAS 79 MG/DL. NO RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND NO PATIENTS WERE AFFECTED. THE LOT NUMBER OF THE BICARBONATE REAGENT WAS 62804201. THE LOT NUMBER OF THE CALCIUM REAGENT WAS 62802801. THE LOT NUMBER OF THE TOTAL PROTEIN REAGENT WAS 63138001. THE LOT NUMBER OF THE ALBUMIN REAGENT WAS 62946201 AND THE LOT NUMBER OF THE GLUCOSE REAGENT WAS 61943801. THE FIELD SERVICE REPRESENTATIVE STATED THE USER FOUND AN OBSTRUCTION IN THE SAMPLE PROBE WHICH WAS RESOLVED THROUGH THE OPERATOR'S MAINTENANCE. HE FOUND THE RINSE MECHANISM DISPENSE WAS ON THE LOW END OF THE SPECIFICATIONS. HE REPLACED A RINSE LINE TUBING, VERIFIED THE FLUIDIC DISPENSE WAS TO SPECIFICATION AND VERIFIED THE PROBE ADJUSTMENT AND MECHANISM CHECKS PASSED. TO VERIFY THE ANALYZER OPERATION, HE RAN AN INSTRUMENT PRECISION CHECK WHICH PASSED AND THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS NEAR THE MEAN VALUES. HE DETERMINED THE INSTRUMENT WAS PERFORMING WITHIN THE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR