BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPASE

    MDR report key: 2114853 · Received June 6, 2011

    Report

    Report Number
    2050012-2011-02081
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL LIMITED
    Product Code
    CDT
    PMA / PMN Number
    K963424
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THIS ISSUE RE-OCCURS EVERY FEW WEEKS, WHEREBY THE LABORATORY WILL OBTAIN A SAMPLE RESULT WHICH DISPLAYS ATYPICAL LIPASE VALUES. THE SAMPLING ORDER AND CONTAMINATION PARAMETERS HAVE BEEN CHECKED BY THE CUSTOMER CONTACT AND ARE CORRECT. THE SPECIMEN WAS RETURNED TO BCI (CO. CLARE) FOR INVESTIGATION. TESTING WAS CONDUCTED OVER THREE LOTS OF LIPASE REAGENT, INCLUDING THE REAGENT LOTS USED BY THE CUSTOMER AT THE TIME OF THIS EVENT. THE RESULTS FROM BOTH, THE AU681-03E AND THE REFERENCE INSTRUMENT ACROSS THE THREE REAGENT LOTS ARE PROVIDED BELOW. A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. ANALYZER: AU681-03E, RG LOT 9830: 20.57, RG LOT 1026: 17.76, RG LOT 1173: 16.18; ALTERNATE INSTRUMENT, 21.15, 18.83, 16.65. UNITS: U/L.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH LIPASE RESULT OF 171.0U/L GENERATED BY THE AU681-03E CHEMISTRY ANALYZER. THE SAMPLE WAS REPEATED TWO MORE TIMES ON THIS INSTRUMENT AND THE FOLLOWING RESULTS WERE OBTAINED: 14.1U/L AND 218.2U/L. THE ELEVATED RESULT WAS NOT REPORTED OUT OF THE LAB. THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPASE LIPASE REAGENT CDT BECKMAN COULTER BIOMEDICAL LIMITED NA 1026

    Patients

    Seq Age Sex Outcome Treatment
    1