BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172407 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01793
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 27, 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. 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 EXPERIENCING ELEVATED BLOOD GLUCOSE OF UP TO 500 MG/DL DUE TO THE INFUSION DEVICE FROM (B)(6) 2011. SHE DOES NOT BELIEVE THE INFUSION DEVICE CORRECTLY DISPLAYS E4 (OCCLUSION) ERROR. SHE INJECTED INSULIN VIA PEN TO LOWER HER BLOOD GLUCOSE AND LATER SWITCHED TO HER BACKUP INFUSION DEVICE. HER NORMAL BLOOD GLUCOSE RANGE IS 80-100 MG/DL. SHE STATED THAT ON (B)(6) 2011, SHE PROGRAMMED A BOLUS AND HEARD NO BEEP AND RE-PROGRAMMED THE BOLUS. SHE STATED THAT AT TIMES THE INFUSION DEVICE SHUTS DOWN WITHOUT ALERT/ERROR MESSAGE. THE PATIENT 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 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 58 YR INSULIN| INSULIN INFUSION SET