BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND PLUS WITH HM

    MDR report key: 2902285 · Received January 8, 2013

    Report

    Report Number
    1226181-2013-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR CAUSED THE EVENT. SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER TECHNICAL SUPPORT (CTS) OBTAINED THE CALIBRATION AND QUALITY CONTROL (QC) DATA FROM THE SYSTEM. AFTER REVIEWING THE DATA, THE CTS DETERMINED THAT THE CUSTOMER MANUALLY ACCEPTED CALIBRATION DATA THAT WAS OUTSIDE OF SPECIFICATION. FURTHER EXAMINATION DETERMINED THAT CALIBRATOR #2 AND CALIBRATOR #3 WERE SWITCHED BY THE CUSTOMER. THE CUSTOMER ALSO INDICATED THAT ALTHOUGH THE QC WAS WITHIN THEIR ESTABLISHED RANGE, THIS RESULT WAS OUTSIDE PEER DATA FOR LEVEL 3 QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DIMENSION XPAND PLUS WITH HM IS SHOWING A QUALITY CONTROL SHIFT TO THE LOW SIDE FOR TROPONIN AFTER CALIBRATION. THE CUSTOMER RAN QUALITY CONTROLS AND CALIBRATORS AND OBTAINED A SLOPE OF 1.35 WHICH IS OUTSIDE THE RANGE OF 0.95 TO 1.05. THE CUSTOMER MANUALLY ACCEPTED THIS CALIBRATION LEVEL. THE CUSTOMER THEN CONTINUED TO PROCESS AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. IT IS NOT KNOWN IF ANY PATIENTS WERE TREATED. NO FURTHER PATIENT INFORMATION WAS PROVIDED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9411 DIMENSION® XPAND PLUS WITH HM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1