BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3062158 · Received April 16, 2013

    Report

    Report Number
    2517506-2013-00174
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    KXT
    PMA / PMN Number
    K093441
    Removal / Correction Number
    2517506-03-06-2013-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 CALIBRATOR LOT 2KD052 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 (B)(4), 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. THE CUSTOMER COMPLAINED OF THE SHIFT UPWARD IN QC RESULTS WHEN PUTTING A NEW, NON-IMPACTED LOT INTO USE. THE CUSTOMER ACKNOWLEDGED THAT THEY HAD RECEIVED A COPY OF THE URGENT MEDICAL DEVICE RECALL LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A UPWARD SHIFT OF DIGOXIN RESULTS OBTAINED ON QC SAMPLES UPON CALIBRATION WITH A NEW LOT OF CALIBRATOR. PRIOR TO THE SWITCH TO THE NEW LOT OF CALIBRATOR, PATIENT RESULTS HAD BEEN REPORTED TO PHYSICIANS WITH THE PRIOR LOT OF CALIBRATOR, 2KD052, WHICH WAS A LOT INCLUDED IN AN URGENT MEDICAL DEVICE RECALL DUE TO CAUSING BIASED LOW RESULTS. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED AS A RESULT OF BIASED LOW DIGOXIN RESULTS OBTAINED AND REPORTED WHEN THE PRIOR LOT OF CALIBRATOR, 2KD052, WAS IN USE. 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
    162247 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM DRUG 4 CALIBRATOR KXT SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 2KD052

    Patients

    Seq Age Sex Outcome Treatment
    1