BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2011801 · Received February 9, 2011

    Report

    Report Number
    2183996-2011-00184
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 26, 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
    UK
    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, THE PISTON ROD OF THE INFUSION DEVICE DOES NOT RETRACT CORRECTLY AND THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE. HE STATED INSULIN WAS BEING DELIVERED THROUGH THE INFUSION DEVICE, BUT NOT ENOUGH AND NOT AS FAST AS IT SHOULD BE. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR OTHER PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND 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 INSULIN INFUSION SET| INSULIN