BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20

    MDR report key: 1032233 · Received April 21, 2008

    Report

    Report Number
    2050012-2008-00015
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN BEFORE AND AFTER THE EVENT AND RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE SPECIMEN WAS COLLECTED IN A SST TUBE AND WAS ALLOWED TO CLOT AND THEN WAS CENTRIFUGED AT 3,600 RPM FOR 10 MINUTES. THE PT HAS A KNOWN HISTORY OF HIGH CREATININE RESULTS. CUSTOMER RE-TESTED OTHER SAMPLES RUN AT THE SAME TIME AND ALL CREM RESULTS CORRELATED. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO BE CUSTOMER'S LAB AS CUSTOMER REFUSED THE OFFER OF SERVICE BECAUSE THE LOW CREM RESULT APPEARS TO BE SAMPLE SPECIFIC. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY LOW CREATININE (CREM) RESULT THAT WAS GENERATED BY THE SYNCHRON LX20 INSTRUMENT. A PT SAMPLE WAS TESTED FOR CREM AND A RESULT OF 1.1 MG/DL WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED FOR CREM AND REPEATED RESULT WAS 2.6 MG/DL. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. LX20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA