BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1051583 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04136
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THREE PT SAMPLES WITH DISCREPANT POTASSIUM RESULTS. PT 1, INITIAL POTASSIUM GAVE 5.2 MMOL/L; REPEAT GAVE 4.3 MMOL/L. PT 2, INITIAL POTASSIUM GAVE 5.3 MMOL/L; REPEAT GAVE 4.5 MMOL/L. PT 3, INITIAL POTASSIUM GAVE 5.7 MMOL/L; REPEAT GAVE 4.4 MMOL/L. ERRONEOUS RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE OF THE DISCREPANT RESULTS TO BE DUE TO ISE PINCH TUBING CRUSHED, CREATING AN AIR LEAK, AND REPLACED PINCHED TUBING. ADDITIOALLY CLEANED AND CHECKED ALIGNMENT OF SIPPER PROBE AND REACTION WELL. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE MODULAR CORE - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK