BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265

    MDR report key: 2957242 · Received February 5, 2013

    Report

    Report Number
    1217157-2013-00013
    Event Type
    Other
    Date Received
    February 5, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD
    Product Code
    CGX
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THE SENSOR WAS INSTALLED ON THE INSTRUMENT ON (B)(4) 2011, BUT THE FILL SOLUTION WAS NOT REPLENISHED UNTIL (B)(4) 2012 (20 MONTHS). THE RP1265 USER MANUAL INSTRUCTS CUSTOMER TO CHECK FILL SOLUTION WEEKLY AND RE-FILL AS NEEDED. CUSTOMER INSTALLED A NEW IONIZED CALCIUM SENSOR AND THE PT CORRELATION IS GOOD. THE CAUSE FOR THE DISCORDANT IONIZED CALCIUM RESULTS IS UNK.

    Description of Event or Problem · 1

    PHYSICIAN NOTICED THAT IONIZED CALCIUM RESULTS DONE IN THE NICU BETWEEN (B)(6) 2012 SEEMED LOW. QUALITY CONTROL RESULTS WERE WITHIN RANGE. NICU PTS WITH LOW IONIZED CALCIUM RESULTS WERE INFUSED WITH CALCIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47409 RAPIDLAB 1265 RAPIDLAB 1265 CGX SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD

    Patients

    Seq Age Sex Outcome Treatment
    1