BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2171081 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01977
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 28, 2011
    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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED, SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 BECAUSE, SHE WAS SICK AND HER BLOOD GLUCOSE LEVELS WERE ELEVATED. PT REPORTED, SHE TREATED HER BLOOD GLUCOSE LEVELS BY GIVING CORRECTIONS VIA THE INFUSION DEVICE BUT THIS DID NOT HELP. PT STATED, HER BLOOD GLUCOSE LEVEL WAS 595 MG/DL WHEN THE AMBULANCE ARRIVED ON (B)(6) 2011. PT'S TARGET BLOOD GLUCOSE RANGE IS UNDER 200 MG/DL. PT REPORTED, SHE WAS TAKEN OFF OF THE INFUSION DEVICE AND GIVEN INSULIN IV WHEN SHE WAS ADMITTED. PT STATED, THE HOSPITAL DID NOT FIND ANY FAULT WITH THE INFUSION DEVICE. PT REPORTED, SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011 AND HAS BEEN HOME FOR ABOUT A WEEK. PT STATED, HER BLOOD GLUCOSE LEVELS HAVE REMAINED NORMAL. NO PRODUCT RETURN WAS REQUESTED.

    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 69 YR Hospitalization| R INSULIN INFUSION SET| INSULIN