BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 5398313 · Received January 29, 2016

    Report

    Report Number
    1226181-2016-00044
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    January 6, 2016
    Report Date
    January 6, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC OBTAINED INSTRUMENT FILES, WHICH INDICATED INTERMITTENT REAGENT PROBE 1 (R1) FOAMING ISSUES. THE SAMPLE IN QUESTION DID NOT INDICATE R1 ISSUES. THE PROBLEM WITH THE SAMPLE IN QUESTION APPEARED AFTER ADDITION OF THE SAMPLE. THE CCC INSTRUCTED THE CUSTOMER TO PRIME AND INSPECT THE SAMPLE PUMPS TO CHECK IF THERE WERE ANY STALLING, LEAKING OR BUBBLE ISSUES WITH THE SYRINGE. NO SAMPLE FOAMING WAS SEEN ON ANALYTES OTHER THAN CA. THE CCC DETERMINED THAT THE OPTICS SHOWED A BRIGHT AND MISALIGNED LAMP AND INSTRUCTED THE CUSTOMER TO CHECK THE PHOTOMETER DIAGNOSTICS READING, LAMP ALIGNMENT AND MILLIABSORBANCE UNITS (MAU) OFFSET. THE CUSTOMER PERFORMED PHOTOMETER ALIGNMENT TO CHECK LAMP AND ALSO PERFORMED MAU CHECK. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE REPLACED THE SAMPLER, R1 TUBING, SAMPLE METERING SYRINGE, AND VALVE SOLENOID. THE CSE CLEANED AND LUBRICATED THE PUMP PANEL LEAD SCREWS. THE CSE PERFORMED MOTOR TITRATION TESTING AND VERIFIED PHOTOMETER DIAGNOSTICS. THE CSE THEN RAN SYSTEM CHECK, WHICH PASSED. THE CSE INSTRUCTED THE CUSTOMER TO RUN QUALITY CONTROLS. THE CAUSE OF THE DISCORDANT, FALSELY DEPRESSED CA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY DEPRESSED CALCIUM (CA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. 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 DEPRESSED CA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58242 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1