BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2993078 · Received March 7, 2013

    Report

    Report Number
    2517506-2013-00053
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K112142
    Removal / Correction Number
    2517506-03-06-2013-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PROFICIENCY SURVEY SAMPLES AFTER CALIBRATION. PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED AS A RESULT OF THE BIASED LOW DIGOXIN RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BIASED LOW DIGOXIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98298 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM DRUG 4 CALIBRATOR MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 2KD053

    Patients

    Seq Age Sex Outcome Treatment
    1