BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1851262 · Received September 23, 2010

    Report

    Report Number
    2183996-2010-01976
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 13, 2010
    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. 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

    PATIENT REPORTED THE INFUSION DEVICE DOES NOT ALWAYS DISPLAY LOW BATTERY (A2) ALERT. ON (B)(6) 2010, THE INFUSION DEVICE DISPLAYED LOW CARTRIDGE (A1) ALERT, BUT THE INSULIN CARTRIDGE WAS HALF FULL. ON DAY OF REPORT, INFUSION DEVICE DISPLAYED MECHANICAL ERROR (E6). NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PATIENT WAS USING THE INCORRECT TYPE OF BATTERY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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| INSULIN INFUSION SET