BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2062643 · Received April 11, 2011

    Report

    Report Number
    2183996-2011-00947
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    December 28, 2008
    Report Date
    March 13, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT SHE EXPERIENCED TWO LOW BLOOD GLUCOSE EVENTS. SHE STATED SHE IS A "BRITTLE" DIABETIC AND BLOOD GLUCOSE "GOES UP AND DOWN ALL THE TIME." THE FIRST EVENT WAS ON (B)(6) 2008. PATIENT FELL OUT OF BED, BROKE HER SHOULDER, AND WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. PATIENT WAS FOUND PASSED OUT ON THE FLOOR BY A RELATIVE'S BOYFRIEND, AND HE CALLED 911. BLOOD GLUCOSE AT THE TIME WAS UNKNOWN. SHE WAS ADMITTED TO THE HOSPITAL AT NIGHT, TREATED WITH A GLUCOSE IV, AND RELEASED A FEW HOURS LATER. THE SECOND EVENT WAS ON (B)(6) 2009. PATIENT FELL IN THE STREET DUE TO LOW BLOOD GLUCOSE, AND HER SISTER CALLED 911. BLOOD GLUCOSE AT THE TIME WAS UNKNOWN. PATIENT WAS TREATED WITH A GLUCOSE IV AND ADMITTED TO THE HOSPITAL FOR 1 WEEK TO REGULATE BLOOD GLUCOSE. PATIENT REPORTED THAT SHE DOES NOT EAT RIGHT AND THAT IS WHY SHE EXPERIENCES LOW BLOOD GLUCOSE. SHE DOES NOT HAVE A TARGET RANGE. PATIENT DID NOT FEEL WELL DURING TROUBLESHOOTING CALL. SHE CHECKED HER BLOOD GLUCOSE, AND IT WAS 117 MG/DL WHICH WAS "OKAY." 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 64 YR Hospitalization| R INSULIN| 12/19/2009 )| INSULIN INFUSION SET (DATE OF TX: 12/12/2009 -