BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265

    MDR report key: 3463488 · Received November 1, 2013

    Report

    Report Number
    1217157-2013-00203
    Event Type
    Other
    Date Received
    November 1, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 11, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    CIG
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FIELD SERVICE ENGINEER (FSE) WENT ON THE SITE AND CHECKED THE SYSTEM. FSE INDICATED THAT SYSTEM WAS DOWN ON ARRIVAL DUE TO REAGENT FLOW ERRORS AND FOUND BLOCKAGE IN THE PREHEATER TUBING AND REAGENT MANIFOLD. FSE CLEANED THE PRE-HEATER TUBING AND REPLACED THE PRESSURE SENSOR AND REAGENT MANIFOLD. FSE FOUND THAT THE HARNESS COOX INTERCONNECT DAMAGED AT THE SCIF CONNECTION (P50) WHICH HAS BEEN REPLACED AND REBOOTED THE SYSTEM. FSE ALSO FOUND SLOPE ERRORS WITH THE POTASSIUM (K) SENSOR. IT HAS BEEN REFILLED AND SEVERAL CALIBRATION PERFORMED. CUSTOMER RAN SAMPLE AND COMPARED THE RESULTS WITH TWO OTHER ANALYZERS IN THE LAB AND FOUND THAT THE BILIRUBIN VALUES WERE MATCHING. INSTRUMENT IS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 DISCORDANT BILIRUBIN RESULTS ON THE INSTRUMENT. CUSTOMER INDICATED THAT BILIRUBIN RESULTS WERE APPROX +/- 100 MG/DL DIFFERENCE TO THE LAB RESULTS AND TO A ALTERNATE INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562442 RAPIDLAB 1265 RL 1265 CIG SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1