BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION

    MDR report key: 121584 · Received September 18, 1997

    Report

    Report Number
    1225153-1997-00020
    Event Type
    Malfunction
    Date Received
    September 18, 1997
    Date of Event
    August 17, 1997
    Report Date
    September 12, 1997
    Manufacturer
    DADE INTL., INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    QC FOR POTASSIUM GAVE LOW/BORDERLINE RESULTS. EXPECTED: 3.7-4.5 MMOL/L OBTAINED: 3.6, 3.7 (REPEAT) SEVEN PT SAMPLES WERE TESTED AND LOW RESULTS WERE REPORTED TO PHYSICIANS. REPEAT RESULTS WERE OBTAINED AFTER INSTRUMENT MAINTENANCE. PATIENT A-2 INITIAL 2.6 REPEAT 3.2. PATIENT B- INITIAL 2.5 REPEAT 3.6 PATIENT C- INITIAL 3.0- REPEAT 4.4 PATIENT D- INITIAL 2.7 REPEAT 3.8 PATIENT E- INITIAL 2.8- REPEAT 4.3 PATIENT F- INITIAL 2.8 REPEAT 4.3 PATIENT G- INITIAL- 3.0 REPEAT NOT REPEATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY ANALYZER JJC DADE INTL., INC. AR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN