BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 500

    MDR report key: 3140117 · Received May 22, 2013

    Report

    Report Number
    1217157-2013-00077
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT SODIUM (NA+) RESULTS IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCORDANT SODIUM (NA+) RESULTS ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226828 RAPIDPOINT 500 RAPIDPOINT 500 GKR SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD

    Patients

    Seq Age Sex Outcome Treatment
    1