BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1458702 · Received May 7, 2009

    Report

    Report Number
    1823260-2009-03263
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    April 13, 2009
    Report Date
    May 7, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED LOW SODIUM RESULTS FOR APPROXIMATELY 150 PTS BETWEEN TWO COBAS INSTRUMENTS AT THE SITE AND PROVIDED 158 EXAMPLES. OF THESE, 76 SAMPLES TESTED ON THIS ANALYZER WERE CONSIDERED DISCREPANT. ALL REPEATED TESTING WAS PERFORMED ON COBAS 6000 SERIAL NUMBER (B)(4). ALL RESULTS ARE INITIAL, REPEAT AND ARE IN MMOL PER L. SAMPLE: 1: 133, 139. SAMPLE 2: 133, 139. SAMPLE 3: 129, 136. SAMPLE 4: 131, 137. SAMPLE 5: 127, 133. SAMPLE 6: 132. 139. SAMPLE 7: 131, 138. SAMPLE 8: 130, 137. SAMPLE 9: 133, 140. SAMPLE 10: 132, 139. SAMPLE 11: 132, 138. SAMPLE 12: 130, 137. SAMPLE 13: 124, 132. SAMPLE 14: 125, 131. SAMPLE 15: 120, 127. SAMPLE 16: 134, 141. SAMPLE 17: 130, 137. SAMPLE 18: 123, 130. SAMPLE 19: 128, 134. SAMPLE 20: 128, 134. SAMPLE 21: 126, 133. SAMPLE 22: 134, 141. SAMPLE 23: 133, 140. SAMPLE 24: 129, 135. SAMPLE 25: 126, 133. SAMPLE 26: 129, 136. SAMPLE 27: 132, 138. SAMPLE 28: 121, 127. SAMPLE 29: 131, 137. SAMPLE 30: 133, 139. SAMPLE 31: 127, 133. SAMPLE 32: 128, 135. SAMPLE 33: 118, 124. SAMPLE 34: 132, 141. SAMPLE 35: 131, 138. SAMPLE 36: 127, 133. SAMPLE 37: 132, 139. SAMPLE 38: 130, 137. SAMPLE 39: 132, 138. SAMPLE 40: 134, 141. SAMPLE 41: 134, 140. SAMPLE 42: 131, 137. SAMPLE 43: 130, 137. SAMPLE 44: 134, 140. SAMPLE 45: 130, 137. SAMPLE 46: 131, 138. SAMPLE 47: 130, 136. SAMPLE 48: 129, 135. SAMPLE 49: 130, 136. SAMPLE 50: 132, 139. SAMPLE 51: 129, 136. SAMPLE 52: 132, 139. SAMPLE 53: 132, 138. SAMPLE 54: 133, 139. SAMPLE 55: 131, 138. SAMPLE 56: 134, 141. SAMPLE 57: 131, 139. SAMPLE 58: 133, 139. SAMPLE 59: 134, 141. SAMPLE 60: 131, 138. SAMPLE 61: 133, 139. SAMPLE 62: 133, 139. SAMPLE 63: 127, 136. SAMPLE 64: 130, 136. SAMPLE 65: 131, 138. SAMPLE 66: 131, 137. SAMPLE 67: 127, 134. SAMPLE 68: 129, 135. SAMPLE 69: 134, 141. SAMPLE 70: 130, 137. SAMPLE 71: 132, 139. SAMPLE 72: 124, 132. SAMPLE 73: 131, 137. SAMPLE 74: 129, 136. SAMPLE 75: 133, 140. SAMPLE 76: 130, 138. THE INITIAL RESULTS WERE REPORTED AND THE USER STATED SOME OF THE PTS WERE TREATED BASED ON THE RESULTS BUT SHE DID NOT KNOW WHICH ONES OR HOW MANY. IT IS NOT KNOWN WHAT TREATMENT WAS RECEIVED. THE USER STATED SHE DID NOT KNOW IF ANY PATIENT WERE ADVERSELY AFFECTED AND COULD NOT PROVIDE THAT INFORMATION. THE FIELD SERVICE REP FOUND A CLOT IN THE SIPPER NOZZLE. HE REMOVED THE CLOT AND FLUSHED OUT THE ISE SYSTEM. ISE CHECKS, CALIBRATION AND QC WERE PERFORMED TO VERIFY THE ANALYZER PERFORMANCE. ON A SUBSEQUENT VISIT, HE FOUND THE RINSE MECHANISM VACUUM LINE FOR THE CELL WASH DETERGENT WAS RESTRICTED BY IMPROPER ROUTING OF THE RINSE MECHANISM TUBING GUARD. HE CHECKED THE ISE SYSTEM AND ELECTRODES FOR PROPER ALIGNMENT AND CONNECTIONS. HE MANUALLY RECONDITIONED THE ISE ELECTRODES AND TUBING. HE ALSO REMOVED THE CABLE GUARD AND REROUTED THE TUBING TO ELIMINATE RESTRICTIONS. ISE CALIBRATION AND QC WERE PERFORMED TO VERIFY THE ANALYZER PERFORMANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK