BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDLAB 1265

    MDR report key: 3981038 · Received August 5, 2014

    Report

    Report Number
    1217157-2014-00109
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SIEMENS INVESTIGATION DATA, THE SENSOR UNDER-RECOVERED HIGHGL(QUALITY CONTROL MATERIAL) ON 7/8/2014 WHICH IS THE END OF LIFE MARKER FOR GLUCOSE AND LACTATE. THE LACTATE SENSOR SHOULD HAVE BEEN REPLACED ON 7/8/2014 BUT WAS NOT REPLACED UNTIL 7/10/2014 AFTER THE AQC LEVEL 1 UNDER-RECOVERED. CUSTOMER SHOULD NOT HAVE RUN PATIENT SAMPLES WHEN AUTOMATIC QUALITY CONTROL (AQC) RESULT FOR LACTATE WAS OUT OF RANGE. THE EVENT IS OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT TWO PATIENT SAMPLES WERE RUN WHEN LACTATE AUTOMATIC QUALITY CONTROL (AQC) RESULT WAS OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456686 RAPIDLAB 1265 RL 1265 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1