BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2011780 · Received February 9, 2011

    Report

    Report Number
    2183996-2011-00195
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 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

    PATIENT REPORTED DROPPING THE INFUSION DEVICE ON THE FLOOR ON (B)(6) 2011. PATIENT STATED SHE CHECKED THE INFUSION DEVICE AND THERE WERE NO FUNCTION PROBLEMS. PATIENT REPORTED SHE WOKE UP ON (B)(6) 2010 AND NOTICED THE INFUSION DEVICE WAS 'DEAD'. PATIENT STATED SHE CHANGED THE BATTERY; NO SUCCESS. PATIENT REPORTED A BLOOD GLUCOSE LEVEL OF 20.0 MMOL/L (360 MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 6-7 MMOL/L (108-126 MG/DL). PATIENT STATED SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND TOOK A BOLUS VIA THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 42 YR INSULIN INFUSION SET| INSULIN