BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2002776 · Received February 8, 2011

    Report

    Report Number
    2183996-2011-00110
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 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
    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 THE INFUSION DEVICE DOES NOT PROPERLY DISPLAY E4 (OCCLUSION) ERROR. ON (B)(6) 2011, THE PT CHANGED THE INFUSION SET AT 6:00AM. AT 11:45PM, HER BLOOD GLUCOSE MEASURED 11.2 MMOL/L (202 MG/DL) AND SHE BOLUSED 2 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. ON (B)(6) 2011 AT 8:30AM, HER BLOOD GLUCOSE MEASURED 15.9 MMOL/L (286 MG/DL) AND SHE INJECTED 5 UNITS OF INSULIN VIA SYRINGE. SHE STATED, SHE USES THE INSULIN CARTRIDGE FOR 8-9 DAYS, INFUSION SITE FOR 2 DAYS, AND INFUSION TUBING FOR 8 DAYS. SHE WAS ADVISED TO REFER TO THE USER'S GUIDE. 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 PUMP 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 45 YR INSULIN| INSULIN INFUSION SET