BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2031007 · Received March 16, 2011

    Report

    Report Number
    2183996-2011-00542
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED SHE WENT TO THE HOSPITAL WITH DKA AND WAS JUST RELEASED YESTERDAY. PATIENT STATED SHE FEELS THE INFUSION DEVICE IS NOT DELIVERING INSULIN PROPERLY. PATIENT REPORTED SHE FEELS HER BLOOD GLUCOSE HAS BEEN ELEVATED AND ABOVE NORMAL FOR THE PAST YEAR AS A RESULT OF THE INFUSION DEVICE. PATIENT STATED ON (B)(6) 2011, SHE WOKE UP AND HER BLOOD GLUCOSE WAS 496 MG/DL. PATIENT REPORTED SHE HAD TO COME HOME FROM WORK AND ENDED UP GOING TO THE HOSPITAL WHERE SHE WAS ADMITTED. PATIENT STATED BY THE TIME SHE GOT TO THE HOSPITAL, SHE WAS DIAGNOSED WITH DKA AND TAKEN OFF OF THE INFUSION DEVICE AND PLACED ON AN INSULIN IV. PATIENT REPORTED SHE WAS ALSO GIVEN LANTUS IN THE MORNINGS. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 100-125 MG/DL. PATIENT STATED SHE IS CURRENTLY ON HER BACKUP INFUSION DEVICE AND HAS NO CONCERNS. PATIENT REPORTED THE HOSPITAL INFORMED HER THE INFUSION DEVICE WAS NOT WORKING SINCE HER BLOOD GLUCOSE WAS SO ELEVATED. PATIENT STATED SHE FEELS THE INFUSION DEVICE WAS NOT DELIVERING INSULIN PROPERLY. VERIFIED NO ALARMS OR OCCLUSIONS OCCURRED. UNABLE TO ACCESS BOLUS HISTORY AS PATIENT DOES NOT HAVE A BATTERY IN THE INFUSION DEVICE. ON FOLLOW UP CALL ON (B)(6) 2011, PATIENT REPORTED ONGOING CONCERNS REGARDING THE INFUSION DEVICE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| R INSULIN, DATE OF TREATMENT: (B)(6) 2011| INSULIN INFUSION SET| DATE OF TREATMENT: (B)(6) 2011