BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS ALCOHOL (ETOH) REAGENT

    MDR report key: 2215522 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-03778
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DMT
    PMA / PMN Number
    K000410
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. THE CUSTOMER'S CALIBRATION AND QUALITY CONTROL DATA SHOWED NO ERRORS. BEC HOTLINE PERSONNEL SUGGESTED TO THE CUSTOMER TO RUN A DI WATER BLANK AS A TEST SAMPLE TO CONFIRM HIGH RESULTS. A BLANK TEST SAMPLE RESULTING 0.007 G/DL OR HIGHER WOULD INDICATE A PROBLEM WITH THE REAGENT. A NEW LOT OF REAGENT SEEMED TO RESOLVE THE PROBLEM. BEC SENT THE CUSTOMER ENVIRONMENTAL CAPS TO ENSURE REAGENT INTEGRITY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING ERRONEOUSLY HIGH ETHANOL (ETOH) RESULTS FOR TWO PATIENTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, USED IN CONJUNCTION WITH SYNCHRON SYSTEMS ALCOHOL (ETOH) REAGENT (LOT M011697). RERUN OF PATIENT SAMPLES USING A DIFFERENT LOT OF SYNCHRON SYSTEMS ALCOHOL (ETOH) REAGENT (LOT M101930) YIELDED LOWER RESULTS. THE ELEVATED ETOH RESULTS WERE REPORTED OUT OF THE LAB BUT WERE AMENDED WITH RERUN RESULTS. THE CUSTOMER CONFIRMED THAT THERE WAS NO EFFECT ON PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® SYSTEMS ALCOHOL (ETOH) REAGENT ALCOHOL TEST SYSTEM DMT BECKMAN COULTER, INC. NA M011697

    Patients

    Seq Age Sex Outcome Treatment
    1