BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2072341 · Received April 28, 2011

    Report

    Report Number
    2050012-2011-01355
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NEONATE WITH A POSSIBLE SAMPLE INTEGRITY ISSUE AND COLLECTED IN AN SST TUBE WITH POSSIBLE CLOTTING. PATIENT IS BEING MONITORED DAY-TO-DAY BASIS.SERVICE WAS NOT REQUESTED OR GENERATED AS THIS IS A SAMPLE SPECIFIC EVENT.THE ERRONEOUSLY LOW RESULT APPEARS TO BE DUE TO A SHORT SAMPLE; HOWEVER, THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS POST-MOD CUSTOMER VIA THE PROSERVICE INTERNAL MONITORING, INDICATING THAT A LOW GLUCOSE (GLUCM) NEONATE RESULT WAS OBTAINED WHILE RUNNING IN DUPLICATE MODE, GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER DID NOT CALL AND COMPLAIN TO BCI ABOUT THIS SAMPLE.INITIAL GLUCOSE RESULT YIELDED 64 MG/DL FOLLOWED BY A RERUN RESULT OF 51 MG/DL. PER THE CUSTOMER, SAMPLE QUANTITY WAS INSUFFICIENT SO A SECOND RERUN WAS NOT PERFORMED. PATIENT WAS BEING MONITORED SO THE RESULT WAS NOT AMENDED.PATIENT TREATMENT WAS NOT AFFECTED IN REGARD TO THIS EVENT AS THE CUSTOMER VERIFIES THE RESULTS PRIOR TO REPORTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1