BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 4251890 · Received November 14, 2014

    Report

    Report Number
    1226181-2014-00580
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    PDJ
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED HB1C RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2014-00580 WAS FILED ON NOVEMBER 14, 2014.ADDITIONAL INFORMATION/ CORRECTION (10/21/14): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE REAGENT PROBE 1 TUBING DUE TO A PIN HOLE, PRIMED THE SYSTEM, AND RAN A SYSTEM CHECK. QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED HB1C RESULTS IS UNKNOWN.THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT WITH A NEW FLEX REAGENT, RESULTING WITHOUT CHANGE. THE SAMPLE WAS THEN REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING LOWER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED HB1C RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738027 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER PDJ SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1