BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2213698 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-04480
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER REPLACED ALL OF THE TUBING ON THE PHOSM MODULE AND PERFORMED LAMP CALIBRATION TO RESOLVE THE ISSUE. ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING THE INSTRUMENT BACK INTO SERVICE, A DEFINITIVE ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRATIC PHOSPHORUS (PHOSM) RESULTS WERE GENERATED ON A UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. DATA PROVIDED BY THE CUSTOMER INDICATES THAT THE INITIAL RESULT WAS REPEATED ON THE SAME INSTRUMENT IN DUPLICATE. REPEAT RESULTS WERE DIFFERENT FROM THE INITIAL RESULT, AND EACH OTHER. THE ERRATIC RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. DATA PROVIDED BY THE CUSTOMER ALSO DEMONSTRATED THAT 5 ADDITIONAL PHOSPHORUS RESULTS, FOR DIFFERENT PATIENTS, WERE GENERATED ON THE UNICEL DXC 800 SYNCHRON SYSTEM AND CONFIRMED AS VALID BY A REPEAT TEST PERFORMED ON ANOTHER INSTRUMENT. THESE RESULTS WERE NOT REGARDED AS ERRATIC. THE INSTRUMENT PHOSPHORUS QUALITY CONTROL (QC) RESULTS DID NOT RECOVER WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS THE DAY PRIOR TO THE EVENT. ADDITIONALLY, INSTRUMENT QC WARNINGS WERE GENERATED THE DAY PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR