BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 3781597 · Received April 30, 2014

    Report

    Report Number
    1823260-2014-03108
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEY WERE HAVING PROBLEMS WITH CALIBRATING THE ION SELECTIVE ELECTRODE (ISE) TESTS. THE CUSTOMER MASKED THE TESTS AND CHECKED THE ISE PROBE. THE PROBE APPEARED TO HAVE A PIECE OF "CHEMWIPE" STUCK INSIDE IT. THE CUSTOMER MANUALLY CLEANED THE PROBE AND "STYLETTED" IT. CALIBRATION WAS THEN STABLE AND QUALITY CONTROLS WERE WITHIN RANGE. THE CUSTOMER THEN REPEATED PATIENT SAMPLES THAT WERE RUN AROUND THE TIME OF THE CALIBRATION ISSUE. THE CUSTOMER FOUND THAT ISE RESULTS WERE AFFECTED FOR A TOTAL OF "16- 17" PATIENTS. THE CUSTOMER WAS ASKED, BUT DID NOT PROVIDE THE SPECIFIC NUMBER OF PATIENT SAMPLES AFFECTED. OF THE "16-17" PATIENT SAMPLES, THE CUSTOMER PROVIDED EXAMPLES OF FOUR PATIENTS THAT HAD ERRONEOUS ISE SODIUM, ISE POTASSIUM, AND ISE CHLORIDE RESULTS. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER OR A C501 ANALYZER. THE CUSTOMER WAS ASKED, BUT REFUSED TO SPECIFY WHICH ANALYZER WAS USED TO REPEAT EACH SAMPLE. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER STATED THAT THEY ISSUED FOURTEEN CORRECTED REPORTS, BUT DECLINED TO PROVIDE INFORMATION AS TO WHETHER THE PROVIDED EXAMPLES WERE INCLUDED AS SOME OF THE FOURTEEN THAT HAD CORRECTED REPORTS. THE CUSTOMER STATED THAT MOST OF THE ERRONEOUS RESULTS WERE ACCOMPANIED BY DATA FLAGS, BUT THE CUSTOMER REFUSED TO PROVIDE INFORMATION ON WHICH OF THESE RESULTS WERE FLAGGED. PATIENT SAMPLE ONE INITIALLY RESULTED AS 129 MMOL/L FOR ISE SODIUM, 3.5 MMOL/L FOR ISE POTASSIUM, AND 96 MMOL/L FOR ISE CHLORIDE. THE SAMPLE WAS REPEATED AND RESULTED AS 140 MMOL/L FOR ISE SODIUM, 4.0 MMOL/L FOR ISE POTASSIUM, AND 106 MMOL/L FOR ISE CHLORIDE. PATIENT SAMPLE TWO INITIALLY RESULTED AS 127 MMOL/L FOR ISE SODIUM, 4.3 MMOL/L FOR ISE POTASSIUM, AND 81 MMOL/L FOR ISE CHLORIDE. THE SAMPLE WAS REPEATED AND RESULTED AS 139 MMOL/L FOR ISE SODIUM, 4.9 MMOL/L FOR ISE POTASSIUM, AND 90 MMOL/L FOR ISE CHLORIDE. PATIENT SAMPLE THREE INITIALLY RESULTED AS 119 MMOL/L FOR ISE SODIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 127 MMOL/L FOR ISE SODIUM. PATIENT SAMPLE FOUR INITIALLY RESULTED AS 126 MMOL/L FOR ISE SODIUM AND 2.6 MMOL/L FOR ISE POTASSIUM. THE SAMPLE WAS REPEATED AND RESULTED AS 135 MMOL/L FOR ISE SODIUM AND 4.0 MMOL/L FOR ISE POTASSIUM. THE CUSTOMER STATED THAT 2 OF THE "16-17" PATIENTS WERE TREATED BASED ON ERRONEOUS RESULTS, BUT THE CUSTOMER REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION ON THESE PATIENTS. THE CUSTOMER ALSO DECLINED TO PROVIDE INFORMATION ON WHETHER THE 2 TREATED PATIENTS WERE THE SAME PATIENTS AS THE EXAMPLES PROVIDED. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ASKED, BUT REFUSED TO PROVIDE LOT NUMBERS AND EXPIRATION DATES FOR THE ISE SODIUM, ISE POTASSIUM, AND ISE CHLORIDE ELECTRODES. THE CUSTOMER DECLINED SERVICE SINCE THE CAUSE OF THE ISSUE WAS KNOWN AND HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260452 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1