BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CX ALANINE AMINOTRANSFERASE REAGENT CARTRIDGE

    MDR report key: 2408138 · Received January 10, 2012

    Report

    Report Number
    2050012-2012-00075
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 9, 2011
    Report Date
    December 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K952427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REAGENT CARTRIDGE WAS NOT RETURNED BY CUSTOMER, AND CREDIT WAS ISSUED TO CUSTOMER'S ACCOUNT FOR THE DEFECTIVE, LEAKING SHIPMENT. (B)(4). CUSTOMER DID NOT RETURN SHIPMENT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT WHILE UNPACKING A SHIPMENT OF CX ALANINE AMINOTRANSFERASE (ALT) REAGENT CARTRIDGE, LOT #T106012, ONE OF THE REAGENT KITS APPEARED TO BE LEAKING. UPON FURTHER INSPECTION, CUSTOMER DISCOVERED THAT ONE CARTRIDGE IN THE ALT KIT WAS, IN FACT, LEAKING. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE CARTRIDGE OR THE SHIPMENT BOX. THE LEAK APPEARED TO BE COMING FROM THE BASE OF THE CARTRIDGE, WHERE THE SIDE OF THE CARTRIDGE IS FUSED TO THE BASE. CUSTOMER STATED THAT NO ONE WAS HARMED, INJURED OR EXPOSED TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CX ALANINE AMINOTRANSFERASE REAGENT CARTRIDGE NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA BECKMAN COULTER, INC. ALT REAGENT T106012

    Patients

    Seq Age Sex Outcome Treatment
    1