BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL WITH HM

    MDR report key: 3103608 · Received May 9, 2013

    Report

    Report Number
    1226181-2013-00214
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SUPPORT SPECIALIST (TSS) WAS CONTACTED BY THE CUSTOMER. THE TSS REVIEWED THE DATA FILES AND INSTRUCTED THE CUSTOMER TO REPLACE THE SAMPLE PROBE, RESEAT THE REAGENT 1 PROBE, RUN PRECISION AND QC. THE TSC DETERMINED THAT THE CAUSE OF THE DISCORDANT CREATININE RESULT WAS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CREATININE RESULT WAS GENERATED BY THE DIMENSION RXL WITH HM SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED ON THE SAME SYSTEM AND THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204315 DIMENSION RXL WITH HM ANALYZER, CHEMISTRY JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1