BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1678154 · Received May 6, 2010

    Report

    Report Number
    2183996-2010-00931
    Event Type
    Injury
    Date Received
    May 6, 2010
    Date of Event
    April 24, 2010
    Report Date
    April 27, 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
    IT
    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 THE INFUSION DEVICE DOES NOT PROPERLY DELIVER INSULIN. SHE STATED SHE CHANGED THE INFUSION SITE, TUBING, AND INSULIN CARTRIDGE ON (B) (6) 2010 AND HER BLOOD GLUCOSE HAS BEEN ELEVATED TO UP TO 300 MG/DL SINCE THAT TIME. HER NORMAL BLOOD GLUCOSE LEVEL IS 130 MG/DL. SHE STATED SHE CHANGED THE INFUSION SET 5 MORE TIMES AND HER BLOOD GLUCOSE ELEVATED TO 500 MG/DL. SHE INJECTED INSULIN VIA PEN UNTIL SHE RETURNED HOME ON (B) (6) 2010. WHEN SHE RETURNED HOME, SHE CHANGED THE INFUSION SITE BUT HER BLOOD GLUCOSE REMAINED ELEVATED TO 200-430 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 REQUESTED TO BE RETURNED FOR EVAL.

    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 Other| R INSULIN| INSULIN INFUSION SET