BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2914391 · Received January 14, 2013

    Report

    Report Number
    1823260-2013-00289
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION WAS NOT POSSIBLE DUE TO A LACK OF INFORMATION PROVIDED. NO ROOT CAUSE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM, AND CHLORIDE RESULTS ON THEIR C501 ANALYZER. THE CUSTOMER STATED THAT PATIENT RESULTS ABRUPTLY DROPPED 2-3 HOURS AFTER DAILY MAINTENANCE, CALIBRATION, AND QUALITY CONTROL. THE CUSTOMER STATED THE ISSUE WAS BROUGHT TO HIS ATTENTION BY A PHYSICIAN WHO THOUGHT THE RESULTS WERE LOWER THAN EXPECTED. THE CUSTOMER PERFORMED QUALITY CONTROL AFTER BEING NOTIFIED AND FOUND THE CONTROL RECOVERY WAS LOW AS WELL. THE CUSTOMER NOTICED THERE WAS SALT BUILD-UP ON THE REFERENCE ELECTRODE. THE CUSTOMER CLEANED THE ELECTRODE AND RESEATED IT. THE CUSTOMER PROVIDED DATA FOR EIGHT PATIENTS, OF WHICH SIX HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLES WERE REPEATED ON ANOTHER C501 ANALYZER, SERIAL NUMBER (B)(4). THE FIRST PATIENT'S INITIAL SODIUM RESULT WAS 121 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. THE FIRST PATIENT'S INITIAL POTASSIUM RESULT WAS 3.7 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L. THE FIRST PATIENT'S INITIAL CHLORIDE RESULT WAS 87 MMOL/L. THE REPEAT RESULT WAS 101 MMOL/L. THE SECOND PATIENT'S INITIAL SODIUM RESULT WAS 121 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. THE SECOND PATIENT'S INITIAL POTASSIUM RESULT WAS 3.6 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L. THE THIRD PATIENT'S INITIAL CHLORIDE RESULT WAS 89 MMOL/L. THE REPEAT RESULT WAS 102 MMOL/L. THE THIRD PATIENT'S INITIAL SODIUM RESULT WAS 122 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. THE THIRD PATIENT'S INITIAL POTASSIUM RESULT WAS 3.6 MMOL/L. THE REPEAT RESULT WAS 4.1 MMOL/L. THE THIRD PATIENT'S INITIAL CHLORIDE RESULT WAS 90 MMOL/L. THE REPEAT RESULT WAS 104 MMOL/L. THE FOURTH PATIENT'S INITIAL SODIUM RESULT WAS 128 MMOL/L. THE REPEAT RESULT WAS 144 MMOL/L. THE FOURTH PATIENT'S INITIAL POTASSIUM RESULT WAS 3.7 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L. THE FOURTH PATIENT'S INITIAL CHLORIDE RESULT WAS 94 MMOL/L. THE REPEAT RESULT WAS 107 MMOL/L. THE FIFTH PATIENT'S INITIAL SODIUM RESULT WAS 125 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. THE FIFTH PATIENT'S INITIAL POTASSIUM RESULT WAS 3.9 MMOL/L. THE REPEAT RESULT WAS 4.6 MMOL/L. THE FIFTH PATIENT'S INITIAL CHLORIDE RESULT WAS 92 MMOL/L. THE REPEAT RESULT WAS 104 MMOL/L. THE SIXTH PATIENT'S INITIAL SODIUM RESULT WAS 130 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND ISSUED AS CORRECTED REPORTS. ONE PATIENT WAS TREATED BASED ON THE ERRONEOUS RESULTS, BUT THE CUSTOMER COULD NOT PROVIDE ADDITIONAL INFORMATION. THERE WERE NO OTHER ADVERSE EVENTS. THE SODIUM, POTASSIUM, AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND CRYSTALS IN THE ISE BLOCK. HE CLEANED THE ISE BLOCK. HE REPLACED ALL THE ELECTRODES AND ISE REAGENTS. HE REBUILT THE ISE AND SIP SYRINGE SEALS. THE SYSTEM INITIALIZED WITHOUT ERRORS. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN THE ASSAY RANGES. THE CUSTOMER PERFORMED AN ISE PRECISION WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20875 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1