BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1855158 · Received September 30, 2010

    Report

    Report Number
    2183996-2010-02034
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 26, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED A HYPOGLYCEMIC COMA BETWEEN THE HOURS OF 7 A.M. AND 1:30 P.M. PATIENT RECEIVED AN E6 MECHANICAL ERROR AT 7 A.M. PATIENT DECIDED TO DISCONNECT INFUSION DEVICE AND RETURN TO BED. PATIENT WOKE TO HIS DOG LICKING HIS FACE AND PULLING HIS HAIR AT 1:30 P.M. PATIENT LOST CONSCIOUSNESS BETWEEN 7 A.M. - 1:30 P.M. AND DOES NOT RECALL ANY EVENTS FROM THAT TIME. PATIENT DOES NOT HAVE SYMPTOMS OF HYPOGLYCEMIA. BLOOD GLUCOSE WAS 27 MG/DL WHEN HE WOKE. TARGET BLOOD GLUCOSE IS 140-152 MG/DL. BLOOD GLUCOSE AT TIME OF REPORT WAS 114 MG/DL. PATIENT YELLED FOR HELP AND ROOMMATE BROUGHT CEREAL AND (B)(6) TO TREAT LOW BLOOD GLUCOSE. PATIENT DISCONNECTED TUBING FROM HEADSET WHEN INFUSION DEVICE WAS REMOVED FOLLOWING E6 MECHANICAL ERROR. PATIENT DRANK 2 BEERS BEFORE BED ON (B)(6) 2010, BUT THIS IS NORMAL FOR HIM. PATIENT DID NOT DELIVER ANY BOLUSES THE PREVIOUS NIGHT OR ON THE MORNING OF REPORT. TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY. PATIENT HAS NOT EXPERIENCED INCREASED ABSORPTION OF INSULIN. THERE WERE NO CHANGES TO ACTIVITY LEVEL. PATIENT STARTED A NEW MEDICATION 2 WEEKS AGO FOR A COUGH AND IS TAKING MUCINEX. NO PRODUCT WAS REQUESTED 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 45 YR Required Intervention INSULIN INFUSION SET| INSULIN