BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 500

    MDR report key: 3037247 · Received March 18, 2013

    Report

    Report Number
    1217157-2013-00037
    Event Type
    Other
    Date Received
    March 18, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 24, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCORRECT ENTRY OF THE TEMPERATURE WAS DETERMINED TO BE DUE TO OPERATOR ERROR. THE CUSTOMER WAS PROVIDED INSTRUCTIONS TO CORRECT THE ERROR IN THE INSTRUMENT AND THEY INDICATED THAT THEY WOULD CORRECT THE ERROR IN THEIR LIS. CUSTOMER INDICATED THE RESULTS WERE CORRECTED ON THE INSTRUMENT AND WILL BE CORRECTED IN THE LIS. THEY STATED THEY DID NOT REQUIRE ANY FOLLOW UP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WRONG PATIENT TEMPERATURE WAS ENTERED ON THE RP500 ANALYZER AS 21 DEGREES CELSIUS INSTEAD OF 37 DEGREES CELSIUS AND THE WRONG RESULTS WERE TRANSFERRED TO THE LIS. THESE RESULTS WERE REPORTED TO THE PHYSICIAN, HOWEVER, WHEN THE MISTAKE WAS DISCOVERED THE CUSTOMER INDICATED THAT THE PHYSICIAN WAS CALLED AND GIVEN THE CORRECTED RESULTS. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111807 RAPIDPOINT 500 RAPIDPOINT 500 GKR SIEMENS HEALTHCARE DIAGNOSTICS RP500

    Patients

    Seq Age Sex Outcome Treatment
    1