BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL WITH HM

    MDR report key: 3081852 · Received April 29, 2013

    Report

    Report Number
    1226181-2013-00189
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE DISCORDANT HEMOGLOBIN A1C (HB1C) RESULTS WAS UNKNOWN. THE FSE REPLACED THE SOURCE LAMP, REAGENT 1 SYRINGE AND SOLENOID AND CHECKED PROBE ALIGNMENTS. AFTER THIS MAINTENANCE WAS COMPLETED, THE SYSTEM CHECK PASSED AND QC RECOVERIES WERE ACCEPTABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT FALSELY ELEVATED HEMOGLOBIN A1C (HB1C) PATIENT RESULTS WERE OBTAINED ON A DIMENSION RXL WITH HM INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND THE CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH HEMOGLOBIN A1C (HB1C) PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183428 DIMENSION RXL WITH HM IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1