BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHON CX DELTA CLINICAL SYSTEM

    MDR report key: 2192224 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-03927
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER IDENTIFIED THE ROOT CAUSE OF THE EVENT AND REPAIRED THE INSTRUMENT. THE ROOT CAUSE WAS PINCHED WASHED SOLUTION TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS SODIUM (NA), POTASSIUM (K), CALCIUM (CALC) AND GLUCOSE (GLU3) RESULTS WERE GENERATED FROM A SYNCHRON CX DELTA CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER IDENTIFIED THAT THE INSTRUMENT POSSESSED PINCHED WASH SOLUTION TUBING. THE CUSTOMER REPAIRED THE TUBING. AFTER THE REPAIR, SAMPLES WERE REPEATED IN INSTANCES WHERE THEY DID NOT MEET LABORATORY DELTA CHECK SPECIFICATIONS. RESULTS WERE AMENDED WHERE NECESSARY. INSTRUMENT QUALITY CONTROL (QC) RESULTS PRIOR TO THE EVENT DEMONSTRATED IMPRECISION, AND AFTER THE EVENT RECOVERED HIGH. SAMPLES WERE SERUM OR PLASMA SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHON CX DELTA CLINICAL SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1