BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 5722829 · Received June 14, 2016

    Report

    Report Number
    1823260-2016-00763
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    May 31, 2016
    Report Date
    June 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED ANALYZER ALARMS INDICATING LOW PRESSURE IN THE VACUUM TANK AND RECEIVED QUESTIONABLE LOW ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS FOR APPROXIMATELY 40 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON A COBAS C311 ANALYZER. OF THE DATA PROVIDED, ONLY THE RESULTS FOR 33 SAMPLES WERE ERRONEOUS. RESULTS ARE INITIAL/REPEAT AND ARE IN MMOL/L. PATIENT SAMPLE 1: 126/136. PATIENT SAMPLE 2: 132/143. PATIENT SAMPLE 3: 126/137. PATIENT SAMPLE 4: 128/139. PATIENT SAMPLE 5: 132/139. PATIENT SAMPLE 6: 131/139. PATIENT SAMPLE 7: 130/140. PATIENT SAMPLE 8: 132/138. PATIENT SAMPLE 9: 131/141. PATIENT SAMPLE 10: 131/138. PATIENT SAMPLE 11: 131/137. PATIENT SAMPLE 12: 132/140. PATIENT SAMPLE 13: 131/137. PATIENT SAMPLE 14: 134/141. PATIENT SAMPLE 15: 122/130. PATIENT SAMPLE 16: 129/138. PATIENT SAMPLE 17: 125/133. PATIENT SAMPLE 18: 132/143. PATIENT SAMPLE 19: 134/143. PATIENT SAMPLE 20: 131/139. PATIENT SAMPLE 21: 134/142. PATIENT SAMPLE 22: 130/136. PATIENT SAMPLE 23: 130/141. PATIENT SAMPLE 24: 134/147. PATIENT SAMPLE 25: 131/137. PATIENT SAMPLE 26: 130/137. PATIENT SAMPLE 27: 127/137. PATIENT SAMPLE 28: 129/137. PATIENT SAMPLE 29: 129/139. PATIENT SAMPLE 30: 130/137. PATIENT SAMPLE 31: 133/143. PATIENT SAMPLE 32: 130/138. PATIENT SAMPLE 33: 130/140. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WERE CORRECTED. THERE WAS NO ADVERSE EVENT. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS CONTAMINATION THAT WAS CLOGGING THE ELBOW GOING INTO VACUUM TANK AND HE CLEANED THE ELBOW. THE CUSTOMER PERFORMED CALIBRATION AND QC WITH RESULTS WITHIN SPECIFICATION. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. MOST PROBABLY THE ISSUE WAS DUE TO A QUESTIONABLE CALIBRATION BUT THIS COULD NOT BE CONFIRMED DUE TO INSUFFICIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377916 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR