BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170844 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01893
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 14, 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 REPORTED HIS BLOOD GLUCOSE MEASURED 23 MMOL/L (414 MG/DL) YESTERDAY MORNING AND 4.7 MMOL/L (85 MG/DL) THIS MORNING. HE STATED, THE SAME AMOUNT OF INSULIN WAS DELIVERED AND HE HAS HAD SIMILAR EXPERIENCES OVER THE LAST 2 WEEKS. NO ERROR MESSAGES WERE DISPLAYED AND NO INSULIN LEAKED. 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 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 67 YR INSULIN| INSULIN INFUSION SET