BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CORE WITH 1 ISE

    MDR report key: 4802496 · Received May 28, 2015

    Report

    Report Number
    1823260-2015-03532
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 8, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION DETERMINED THAT THE ISE ANALYZER WAS RELEASED FOR ROUTINE USE AFTER A POOR CALIBRATION WITH AN NA COMPENSATED VALUE OF -6. AFTER CALIBRATION WAS REPEATED WITH A COMPENSATED VALUE OF -1, THE ANALYZER WORKED WITHIN SPECIFICATION. PRODUCT LABELING SPECIFIES THAT THE COMPENSATED VALUE IS DIRECTLY ADDED TO THE RESULT BEFORE THE FINAL RESULT IS DISPLAYED ON THE SCREEN OR PRINTER. THIS DEVIATION IS OBVIOUS TO THE USER AND EXPLAINS THE DIFFERENCES BETWEEN THESE RESULTS.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED UPON INFORMATION PROVIDED, A POSSIBLE ROOT CAUSE MAY BE RELATED TO OPERATOR HANDLING ISSUES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED LOW RESULTS FOR 113 PATIENT SAMPLES TESTED FOR ISE SODIUM ELECTRODE(NA). THE CUSTOMER DIDN'T TRUST THE RESULTS FROM THE 1ST RUN AND REPEATED THE TESTS. OF THE DATA PROVIDED, THE RESULTS FOR 64 PATIENT SAMPLES WERE ERRONEOUS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PRIOR TO THE 1ST RUN OF NA TESTS, CALIBRATION TESTS WERE RUNNING LOW. QUALITY CONTROLS WERE WITHIN THE ACCEPTABLE RANGE. NEW CALIBRATION WAS PERFORMED PRIOR TO THE REPEAT TESTS BEING RUN. FOLLOWING THE REPEAT TESTS, THE PHYSICIANS WERE CONTACTED AND PROVIDED WITH THE CORRECTED RESULT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR THE RESULTS. NO SPECIFIC PATIENT DATA WAS PROVIDED. NO ADVERSE EVENTS WERE REPORTED FOR ANY PATIENT. THE ISE SODIUM ELECTRODE LOT NUMBER WAS PROVIDED AS "F4434." THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346968 MODULAR CORE WITH 1 ISE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1