BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500

    MDR report key: 3811899 · Received May 15, 2014

    Report

    Report Number
    1217157-2014-00067
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K113216
    Removal / Correction Number
    1217157-05-20-2014-003-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS UNDER INVESTIGATION. DEVICE MANUFACTURE DATE FOR SERIAL NO. (B)(4) IS 09/26/2013. DEVICE MANUFACTURE DATE FOR SERIAL NO. (B)(4) IS 09/28/2013.

    Additional Manufacturer Narrative · 1

    CUSTOMERS HAVE BEEN NOTIFIED ABOUT THIS SITUATION. URGENT FIELD SAFETY NOTICE 31512 REV A WAS ISSUED FOR DISTRIBUTION ON 27 MAY 2014.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE RP500 INSTRUMENTS DISPLAYED QUESTION VALUES [...?] FOR SODIUM (NA), POTASSIUM (K), AND CALCIUM (CA) ON A PATIENT SAMPLE AND THE INSTRUMENT DID NOT REPORT ANY RESULTS FOR THESE ANALYTES. CUSTOMER INDICATED THAT A BLOOD GAS SAMPLE WAS COLLECTED FROM A RESUSCITATED PATIENT ON (B)(6) 2014. CUSTOMER INDICATED THAT THEY REPEATED THE MEASUREMENT ON THE SAME SYSTEM(S/N (B)(4)) AND ANOTHER RP500 SYSTEM(S/N (B)(4)) AND BOTH SYSTEMS DISPLAYED QUESTION VALUES [...?] FOR SODIUM (NA), POTASSIUM (K), AND CALCIUM (CA) AND THE SYSTEMS DID NOT REPORT ANY RESULTS FOR THESE ANALYTES. CUSTOMER INDICATED THAT APPROXIMATELY 10 MINUTES LATER, THEY MEASURED A SAMPLE ON THEIR RL1265 BLOOD GAS SYSTEM AND RESULTS FOR THE ALL THE ANALYTES WERE GENERATED INCLUDING SODIUM (NA), POTASSIUM (K), AND CALCIUM (CA). CUSTOMER MENTIONED THAT PATIENT DIED BUT NOT BECAUSE OF THE RP500 DISPLAYED QUESTION VALUES [...?] FOR SODIUM (NA), POTASSIUM (K), AND CALCIUM (CA) AND IT DID NOT REPORT RESULTS FOR THESE ANALYTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291839 RAPIDPOINT 500 RP 500 KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death