BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 3872597 · Received June 13, 2014

    Report

    Report Number
    1217157-2014-00082
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K113216
    Removal / Correction Number
    1217157-05-20-2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT SOME RAPIDPOINT 500 MEASUREMENT CARTRIDGES ARE EXPERIENCING (____?) ERRORS WHEN RUNNING AQC LEVEL 1 OR CVM LEVEL 1 OR 2. CUSTOMERS HAVE BEEN NOTIFIED ABOUT THIS SITUATION. URGENT FIELD SAFETY NOTICE 31512 REV A WAS ISSUED FOR DISTRIBUTION ON 27 MAY 2014. NEW FORMULATION OF SENSOR HAS BEEN RELEASED TO THE FIELD AND CARTRIDGES FROM SERIAL NUMBER (B)(4) SHOULD NOT EXPERIENCE THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PR 500 INSTRUMENTS DISPLAYED (---?) QUESTION VALUE RESULT FOR SODIUM(NA), POTASSIUM(K), AND IONIZED CALCIUM(ICA) ON A PATIENT SAMPLE THAT HAD A HIGH LACTATE RESULT OF 29. CUSTOMER ALSO REPORTED THAT SAMPLE WAS RUN ON 2 OTHER RP500'S WITH THE SAME RESULTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349629 RAPIDPOINT 500 RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1