BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 7903833 · Received September 24, 2018

    Report

    Report Number
    2517506-2018-00544
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 24, 2018
    Manufacturer
    SIEMENS HEATLHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS REVIEWED THE INSTRUMENT FILES AND DETERMINED THAT QUALITY CONTROLS (QCS) WERE WITHIN EXPECTED RANGE ON THE DAY OF THE EVENT. THE INSTRUMENT FILES DEMONSTRATED THAT THE INSTRUMENT WAS PERFORMING AS EXPECTED AND THAT THERE WERE SAMPLE RELATED ISSUES. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. SIEMENS EDUCATED THE CUSTOMER WITH SAMPLE HANDLING TECHNIQUES TO IMPROVE SAMPLE QUALITY AND REMINDED THE CUSTOMER OF THE CENTRIFUGE TIME RECOMMENDED IN THE TUBE MANUFACTURER. SIEMENS DETERMINED THAT INSUFFICIENT SAMPLE VOLUME WAS DELIVERED TO THE CUVETTE WHEN THE SAMPLE WAS INITIALLY PROCESSED. POOR SAMPLE QUALITY POTENTIALLY IMPACTED PROPER SAMPLE ASPIRATION AND DELIVERY OF SAMPLE TO THE CUVETTE, POTENTIALLY CAUSING THE DISCORDANT, FALSELY LOW TSHL RESULT. THE INSTRUMENT IS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW LOCI THYROID STIMULATING HORMONE (TSHL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW TSHL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741900 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEATLHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1