BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® MICROALBUMIN (MA) REAGENT

    MDR report key: 2044583 · Received April 7, 2011

    Report

    Report Number
    2050012-2011-01041
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JIQ
    PMA / PMN Number
    K965035
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS PROVIDED. THE SAMPLE TYPE FOR MICROALBUMIN IS USUALLY RANDOM URINE. CUSTOMER NOTED THAT QC HAS BEEN UNACCEPTABLE. CUSTOMER DID NOT NOTE ANY SYSTEM ERRORS OR ISSUES. IT IS UNKNOWN WHETHER A NEW LOT OR CARTRIDGE OF REAGENT RESOLVED THE ISSUE. SERVICE WAS NOT NEEDED FOR THIS EVENT, AS THIS IS A REAGENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE RESULTS OF CONTROLS AND PATIENT SPECIMENS ARE UNSTABLE FOR THE MICROALBUMIN REAGENT. THE CUSTOMER ALSO STATED THAT THE MICROALBUMIN REAGENT GENERATED DIFFERENT RESULTS WHEN LOADED ON DIFFERENT CARTRIDGES. NO SAMPLE INFORMATION WAS PROVIDED EXCEPT THAT SAMPLE RESULTS WERE DIFFERENT WITH DIFFERENT LOTS OR CARTRIDGES OF REAGENT. NO AFFECT TO PATIENTS WERE REPORTED, AS THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® MICROALBUMIN (MA) REAGENT MICROALBUMIN (MA) REAGENT JIQ BECKMAN COULTER INC. N/A M010304

    Patients

    Seq Age Sex Outcome Treatment
    1