BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1665107 · Received April 20, 2010

    Report

    Report Number
    2183996-2010-00767
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 9, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE BELIEVES THE BOLUS DELIVERY OF THE INFUSION DEVICE IS FAULTY. HE STATED THAT ON (B) (6) 2010 HIS BLOOD GLUCOSE RANGED FROM 130-256 MG/DL DESPITE BOLUSING AND CHANGING INFUSION DEVICE ACCESSORIES. ON (B) (6) 2010 HIS BLOOD GLUCOSE RANGED FROM 192-303 MG/DL AND ON (B) (6) 2010 HIS BLOOD GLUCOSE RANGED FROM 80-303 MG/DL. AT 1:10 PM ON (B) (6) 2010 THE PT SWITCHED TO HIS BACK UP INFUSION DEVICE AND HIS BLOOD GLUCOSE LEVELS DECREASED. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-120 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 54 YR Required Intervention INSULIN| INSULIN INFUSION SET