BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2143716 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01580
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 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 PT REPORTED A1 (CARTRIDGE LOW) ALERT WAS DISPLAYED ON THE INFUSION DEVICE AT 2 PM ON (B)(6) 2011. THE PT CONFIRMED THE ALERT BUT WAS AT WORK AND WAS UNABLE TO CHANGED THE INSULIN CARTRIDGE. THE PT THEN FORGOT TO CHANGE THE CARTRIDGE AND WENT OUT AND BEGAN TO FEEL UNWELL AT 8:45 PM. HER BLOOD GLUCOSE MEASURED 25 MMOL/L (450 MG/DL) AND SHE FOUND THE INSULIN CARTRIDGE WAS EMPTY. THE PT REVIEWED THE ALARM HISTORY AND FOUND THAT NO E1 (CARTRIDGE EMPTY) ERROR WAS LISTED. THE PT CHANGED THE INSULIN CARTRIDGE TO LOWER HER BLOOD GLUCOSE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND 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