BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® ALT REAGENT, 2 X 200 TEST

    MDR report key: 2178375 · Received July 26, 2011

    Report

    Report Number
    2050012-2011-03626
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC EVALUATED THE PHOTOGRAPHS OF THE AFFECTED REAGENT CARTRIDGE AND KIT BOX. LIQUID WAS VISIBLE ON ALT REAGENT CARTRIDGE ALTHOUGH THERE WAS NO LOOSENING OF THE CAP. THE SHIPPING BOX CONTAINED ANOTHER REAGENT, SYNCHRON CHOL (CHOLESTEROL) REAGENT, WHICH HAD LOOSE CAP AND LEAKED. THIS REAGENT IS NON-HAZARDOUS. IT IS POSSIBLE THAT THE LEAK WAS FROM CHOL REAGENT AND NOT FROM ALT, BUT COULD NOT BE CONFIRMED. NOTE: LISTED BELOW IS INFORMATION REGARDING SYNCHRON CHOL REAGENT: CATALOGUE NUMBER: 467825, LOT NUMBER: M101676, DATE OF MANUFACTURING: 02/24/2011, EXPIRATION DATE: 02/29/2012, 510(K): K971505. (B)(4).

    Description of Event or Problem · 1

    AN EMPLOYEE OF BECKMAN COULTER AT (B)(4) REPORT A FLUID LEAK FROM SYNCHRON ALT (ALANINE AMINOTRANSFERASE) REAGENT. THE LEAK WAS FOUND DURING RECEIVING INSPECTION, AND THE OPERATOR WAS WEARING PPE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED MSDS WAS REVIEWED, AND THE FACILITY HAS EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® ALT REAGENT, 2 X 200 TEST NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA BECKMAN COULTER, INC. M102250

    Patients

    Seq Age Sex Outcome Treatment
    1