BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3531656 · Received December 20, 2013

    Report

    Report Number
    2517506-2013-00416
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    November 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MKW
    PMA / PMN Number
    K023065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE QC VARIABILITY AND LOW LEVEL QC OUT OF RANGE RECOVERY IS LIKELY RELATED TO POOR OPEN WELL STABILITY OF THE CSA REAGENT. A CHROME PARTICLE REAGENT USED IN COMMON WITH THE DIMENSION VISTA CSA REAGENT, (B)(4), IS THE LIKELY CAUSE. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED COMPLAINTS REGARDING VARIABILITY OF RECOVERY OF QC AND PATIENT RESULTS WITH THE (B)(4) FLEX REAGENT CARTRIDGE LOTS 12300BB, 12318BB, AND 13011BB. INTERNAL TESTING HAS CONFIRMED ATYPICAL PERFORMANCE AND INCREASES OF >25% OVER SEVERAL DAYS FOR SAMPLES WITH CSA CONCENTRATIONS BELOW 125 NG/ML. DAILY QC CAN DETECT PERFORMANCE VARIATIONS IN THE ASSAY. ERRORS ARE MOST PRONOUNCED BELOW 125 NG/ML WHERE MAINTENANCE THERAPY OCCURS, THEREFORE DOSAGE ADJUSTMENT BASED ON A SINGLE RESULT IS EXTREMELY UNLIKELY. NEVERTHELESS, SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION 13-90 TO CUSTOMERS WHO HAD ORDERED THESE LOTS ADVISING THEM TO DISCONTINUE USE AND TO DISCARD THE DIMENSION VISTA LOTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VARIABILITY OF RECOVERY OF QC SAMPLES FOR CYCLOSPORIN A (CSA) DEPENDING UPON LENGTH OF TIME RUNNING THE SAMPLES WITHIN THE REAGENT OPEN WELL CLAIM. THE CUSTOMER REPORTED QC OUT OF RANGE RESULTS OCCURED UNLESS THE FLEX REAGENT WELLS HAD BEEN PRE-HYDRATED 2-3 HOURS PRIOR TO RUNNING THE CONTROL. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED DUE TO THE VARIABLE RESULTS WITH TIME AFTER HYDRATION OF THE CSA REAGENT OPEN WELLS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT THE VARIABILITY OF RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670694 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM CYCLOSPORINE FLEX® REAGENT CARTRIDGE MKW SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FA3312

    Patients

    Seq Age Sex Outcome Treatment
    1