BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2011897 · Received February 9, 2011

    Report

    Report Number
    2183996-2011-00197
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 18, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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'S MOTHER REPORTED THAT ON (B)(6) 2010, THE PT NOTICED BLOOD IN THE INFUSION TUBING AND INSULIN LEAKED IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PT'S BLOOD GLUCOSE WAS ELEVATED TO 13.4 MMOL/L (241 MG/DL). HER NORMAL BLOOD GLUCOSE LEVEL IS BELOW 10 MMOL/L (180 MG/DL). THE PT DRIED THE CARTRIDGE COMPARTMENT AND CHANGED THE INSULIN CARTRIDGE AND INFUSION SET. THE INSULIN CARTRIDGE REMOVED FROM THE INFUSION DEVICE DID NOT APPEAR TO BE CRACKED OR DAMAGED. ON (B)(6) 2010, THERE WAS AGAIN MOISTURE IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PT WAS ADVISED TO SWITCH TO INJECTION THERAPY. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE, CARTRIDGE, AND INFUSION SET WERE REQUESTED TO BE RETURNED 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 INSULIN| INSULIN INFUSION SET| INSULIN INFUSION PUMP