BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3933921 · Received July 15, 2014

    Report

    Report Number
    1823260-2014-05226
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE HAVE BEEN NO FURTHER ISSUES.

    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 THERE WERE THREE SAMPLES AFFECTED THAT HAD TO HAVE CORRECTED REPORTS SENT. THE CUSTOMER COULD ONLY PROVIDE DATA FOR ONE PATIENT WITH DISCREPANT RESULTS. THE CUSTOMER STATED THE SAMPLE BELONGED TO A PATIENT WHO HAD A CRITICAL CREATININE RESULT CALLED TO THE FLOOR. THE CUSTOMER DID NOT NOTICE THE DISCREPANT RESULTS UNTIL AFTER THEY WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DISCOVERED THE ISSUE BASED ON AN ERRONEOUS ANION GAP. THE PATIENT'S SAMPLE WAS REPEATED ON THE SAME C501 ANALYZER. THE PATIENT'S INITIAL SODIUM RESULT WAS 153 MMOL/L. THE REPEAT RESULT WAS 134 MMOL/L. THE PATIENT'S POTASSIUM RESULT WAS 5.5 MMOL/L. THE REPEAT RESULT WAS 5.0 MMOL/L. THE PATIENT'S CHLORIDE RESULT WAS 86 MMOL/L. THE REPEAT RESULT WAS 97 MMOL/L. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE EVENTS TO THE PATIENTS. THE SODIUM, POTASSIUM, AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND THE CAUSE AND COULD NOT DUPLICATE THE ISSUE. HE CHECKED THE OVERALL ISE FUNCTION. HE CLEANED AND ADJUSTED THE SIPPER PROBES. HE RAN A PRECISION CHECK. THE CUSTOMER RAN TESTS AND QUALITY CONTROL WITHIN THE ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412841 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1