BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3143054 · Received June 3, 2013

    Report

    Report Number
    2517506-2013-00212
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LCP
    PMA / PMN Number
    K963498
    Removal / Correction Number
    2517506-05-17-2013-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED COMPLAINTS OF DIMENSION(R) CHEMISTRY WASH CAUSING QC AND PATIENT SAMPLE RESULT SHIFTS. INTERNAL INVESTIGATION HAS CONFIRMED SHIFTS CAN BE ENCOUNTERED IN TWO SCENARIOS: WHEN AN AFFECTED LOT OF CHEMISTRY WASH IS PLACED ON THE INSTRUMENT FOLLOWING AN UNAFFECTED LOT, A NEGATIVE BIAS WILL BE SEEN ON CTNI, LTNI, TSH, PBNP AND LPBN. A POSITIVE BIAS WILL BE SEEN ON FT4. IF ANY OF THESE ASSAYS ARE CALIBRATED USING AN AFFECTED LOT OF CHEMISTRY WASH, QC SHOULD RETURN WITHIN RANGE; BUT WHEN A SUBSEQUENT UNAFFECTED CHEMISTRY WASH LOT IS PLACED INTO USE, A POSITIVE BIAS WILL BE SEEN ON CTNI, LTNI, TSH, PBNP AND LPBN. A NEGATIVE BIAS WILL BE SEEN ON FT4. SIEMENS HEALTHCARE DIAGNOSTICS INC. ISSUED AN URGENT MEDICAL DEVICE CORRECTION LETTER, (B)(4), IN MAY 2013. THE LETTER STATED THAT SIEMENS HAS CONFIRMED THAT CHANGING THE CHEMISTRY WASH LOT CAN CAUSE QC AND PATIENT SAMPLE RESULT SHIFTS. THE LETTER DIRECTED CUSTOMERS TO DISCONTINUE USE AND DISCARD REMAINING INVENTORY OF THE FOLLOWING LOTS OF CHEMISTRY WASH: RD23031, RD23111, RD23241, RD23311, RD23391, AND RD23461. THE LETTER ADVISED CUSTOMERS TO ENSURE CTNI, LTNI, TSH, FT4, PBNP AND/OR LPBN ASSAYS HAVE BEEN CALIBRATED USING AN UNAFFECTED LOT OF CHEMISTRY WASH.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINS OF QC SHIFTS WITH FREE THYROXIN (FT4) AND THYROID STIMULATING HORMONE (TSH) WITH LOT RD23031 OF DIMENSION(R) CHEMISTRY WASH. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS WHILE QC WAS OUT OF RANGE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE SHIFTS IN TSH & FT4 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245044 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM CHEMISTRY WASH LCP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW RD23031

    Patients

    Seq Age Sex Outcome Treatment
    1