BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1222011 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08222
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 6, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH FALSELY LOW POTASSIUM RESULTS. INITIAL RESULT 2.4 MMOL/L, REPEATED IN 2008, DIFFERENT ANALYZER 3.8 MMOL/L. THE CALIBRATION PERFORMED PRIOR TO THE SAMPLE RUN HAD FAILED AND THE INITIAL PATIENT RESULT WAS FLAGGED. THE FALSE LOW RESULT WAS REPORTED AND THE PATIENT WAS TREATED. TYPE OF TREATMENT GIVEN TO PATIENT WAS NOT PROVIDED. IT IS UNKNOWN IF THE TREATMENT WAS GIVEN BASED SOLELY ON THE LOW POTASSIUM RESULT. ALTHOUGH THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE, HE DISASSEMBLED, CLEANED, ADN CHECKED THE ISE SYSTEM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other