BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2934568 · Received January 30, 2013

    Report

    Report Number
    2517506-2013-00036
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    KXT
    PMA / PMN Number
    K112142
    Removal / Correction Number
    2517506-03-06-2013-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED DIGOXIN RESULTS IS UNKNOWN. THE CALIBRATOR LOT ASSOCIATED WITH THE DEPRESSED DIGOXIN RESULTS IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC. THE ACCOUNT HAS NOT PLACED THE CALIBRATOR LOT INTO USE AND IS RUNNING DIGOXIN SAMPLES ON AN ALTERNATE DIMENSION VISTA(R) SYSTEM WITH DIGOXIN CALIBRATED WITH AN ALTERNATIVE LOT OF DRUG 4 CALIBRATOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR FILED: (B)(4) 2013. ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF LOW QC AND PATIENT RECOVERY FOR DIGOXIN WHEN THIS CALIBRATOR LOT IS USED TO CALIBRATE THE DIGXN METHOD. INTERNAL TESTING HAS CONFIRMED AN AVERAGE 15% LOW BIAS IN THE THERAPEUTIC RANGE OF 0.9 TO 2.0 NG/ML. THE CAUSE OF THE BIAS LOW IN DIGOXIN RECOVERIES IS CALIBRATOR INACCURACY. SIEMENS HEALTHCARE DIAGNOSTICS INC. CONDUCTED A VOLUNTARY RECALL FOR DIMENSION VISTA DRUG 4 CAL (KC460) LOT 2KD052 AND DRUG 4 CAL (KC460A) LOT 2KD053. AN URGENT MEDICAL DEVICE RECALL, COMMUNICATION #13-13, WAS ISSUED IN FEBRUARY 2013 TO IMPACTED CUSTOMERS. CUSTOMERS WERE INSTRUCTED TO IMMEDIATELY DISCONTINUE USE AND TO DISCARD ANY REMAINING INVENTORY OF DIMENSION VISTA DRUG 4 CAL (KC460) LOT 2KD052 AND DRUG 4 CAL (KC460A) LOT 2KD053.

    Description of Event or Problem · 1

    BIASED LOW DIGOXIN RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES IN A LOT CROSS OVER STUDY. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. AFTER A TREND LOW WAS NOTED BY THE LABORATORY, THE SAMPLES WERE REPEATED ON THE ALTERNATE DIMENSION VISTA SYSTEM CALIBRATED WITH A DIFFERENT LOT OF CALIBRATOR AND HIGHER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED AS A RESULT OF THE FALSELY DEPRESSED DIGOXIN RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED DIGOXIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40893 DIMENSION® VISTA CLINICAL CHEMISTRY SYSTEM DRUG 4 CALIBRATOR KXT SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 2KD053

    Patients

    Seq Age Sex Outcome Treatment
    1