BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVO 3 MODULE CORE WITH ISE600

    MDR report key: 2862149 · Received December 7, 2012

    Report

    Report Number
    1823260-2012-06171
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO INSTRUMENT MALFUNCTION COULD BE DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM, AND CHLORIDE RESULTS ON THEIR MODULAR CORE (A) FOR TWO PATIENTS. THE INITIAL PATIENT RESULTS WERE REPORTED. THE INITIAL RESULTS FAILED THE DELTA CHECK AND WERE IMMEDIATELY REPEATED ON ANOTHER MODULAR CORE ANALYZER (B), SERIAL NUMBER (B)(4). THE CUSTOMER IS SURE ONLY THESE TWO SAMPLES WERE AFFECTED. THE CUSTOMER MASKED THE ISE UNIT ON THE CORE AND REPEATED MULTIPLE SAMPLES AND THEY ALL REPEATED WELL. THE FIRST PATIENT'S INITIAL SODIUM RESULT FROM A WAS 122.6 MMOL/L. THE REPEAT RESULT FROM B WAS 142.9 MMOL/L. THE FIRST PATIENT'S INITIAL POTASSIUM RESULT FROM A WAS 3.47 MMOL/L. THE REPEAT RESULT FROM B WAS 4.18 MMOL/L. THE FIRST PATIENT'S INITIAL CHLORIDE RESULT FROM A WAS 121.0 MMOL/L. THE FIRST REPEAT FROM A WAS 106.1 MMOL/L. THE SECOND REPEAT RESULT FROM B WAS 106.1 MMOL/L. THE SECOND PATIENT'S INITIAL SODIUM RESULT FROM A WAS 114.3 MMOL/L. THE FIRST REPEAT RESULT FROM A WAS 141.4 MMOL/L. THE SECOND REPEAT RESULT FROM B WAS 140.5 MMOL/L. THE SECOND PATIENT'S INITIAL POTASSIUM RESULT FROM A WAS 3.68 MMOL/L. THE REPEAT RESULT FROM B WAS 4.68 MMOL/L. THE SECOND PATIENT'S INITIAL CHLORIDE RESULT FROM A WAS 123.9 MMOL/L. THE FIRST REPEAT RESULT FROM A WAS 102.6 MMOL/L. THE SECOND REPEAT RESULT FROM B WAS 101.4 MMOL/L. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE EVENTS. THE SODIUM, POTASSIUM, AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A BENT SAMPLE PROBE WHICH CAUSED IT TO BE TOO FAR FROM THE RINSE STATION AND TOO CLOSE TO THE SIPPER NOZZLE. HE STRAIGHTENED THE SAMPLE PROBE, PERFORMED A PROBE ADJUST, AND ADJUSTED THE SIPPER NOZZLE. HE PERFORMED A PRECISION TEST AND THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL AND EVERYTHING PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVO 3 MODULE CORE WITH ISE600 CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1