BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2980835 · Received February 27, 2013

    Report

    Report Number
    2517506-2013-00057
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 31, 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
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS CONFIRMED CUSTOMER COMPLAINTS OF LOW QC AND PATIENT RECOVERY FOR DIGOXIN WITH THIS CALIBRATOR LOT. 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 (B)(4) 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BIASED LOW DIGOXIN RESULTS WERE OBTAINED ON QC SAMPLES UPON CALIBRATION WITH A NEW LOT OF CALIBRATOR. 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
    85021 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM DRUG 4 CALIBRATOR KXT SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 2KD052

    Patients

    Seq Age Sex Outcome Treatment
    1