BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1944451 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02688
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 19, 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 U.S. 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

    CALLER REPORTED THE CARTRIDGE COMPARTMENT OF THE PT'S INFUSION DEVICE WAS WET WITH INSULIN. CALLER REPORTED THE PT WAS HAVING AN ELEVATED BLOOD GLUCOSE LEVEL. PT'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. CALLER STATED THE INSULIN CARTRIDGE WAS LEAKY. CALLER REPORTED SHE CHANGED THE INFUSION DEVICE AND THE INSULIN CARTRIDGE AND THE PT'S BLOOD GLUCOSE LEVEL IS NOW NORMAL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INSULIN CARTRIDGE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN