BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1941333 · Received December 29, 2010

    Report

    Report Number
    1823260-2010-07730
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE PATIENT CAME INTO THE EMERGENCY ROOM IN A CRITICAL STATE WITH RESPIRATORY FAILURE, A URINARY TRACT INFECTION, SEPSIS, HYPOGLYCEMIA, AND A LEG ULCER. REPORTER ALLEGED THE PATIENT RECEIVED A RESULT OF 396 MG/DL ON THE INFORM SYSTEM AT 8:45 AM AND THE LAB DRAW AT 9:15 CAME BACK WITH 29 MG/DL. REPORTER STATED THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT ON A VENTILATOR BUT SHE COULD NOT PROVIDE ANY TREATMENT INFORMATION ABOUT THE PATIENT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551401

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR