BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265

    MDR report key: 1936028 · Received December 16, 2010

    Report

    Report Number
    1217157-2010-00039
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL POTASSIUM LEVEL WAS NOT REPORTED TO THE PHYSICIAN. CUSTOMER COULD NOT PROVIDE MAKE OR MODEL OF SECOND INSTRUMENT USED FOR TESTING.

    Description of Event or Problem · 1

    DISCORDANT PT POTASSIUM RESULT. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POTASSIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1265 RAPIDLAB 1265 CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. 1265

    Patients

    Seq Age Sex Outcome Treatment
    1