BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1833150 · Received September 9, 2010

    Report

    Report Number
    2183996-2010-01877
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 30, 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
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 430 MG/DL FROM (B)(6) 2010-(B)(6) 2010 DESPITE BOLUSING AND CHANGING THE INFUSION SET. SHE INJECTED INSULIN VIA PEN TO LOWER HER BLOOD GLUCOSE. ON (B)(6) 2010, SHE FOUND THE INFUSION SET TUBING WAS PINK NEAR THE INSULIN CARTRIDGE. ON (B)(6) 2010, THE PISTON ROD OF THE INFUSION DEVICE BECAME BLOCKED DURING EXTENSION. SHE BELIEVES THE PISTON ROD ISSUE CAUSED THE INFUSION TUBING TO BECOME PINK. SHE BELIEVES THE PISTON ROD DISSOLVED IN THE INSULIN CARTRIDGE AND THE SUBSTANCE WAS BEING ADMINISTERED THROUGH THE TUBING. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS 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 Required Intervention INSULIN INFUSION SET| INSULIN