BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2141025 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01620
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 18, 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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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 BOLUS DELIVERY OF THE INFUSION DEVICE IS FAULTY AND THIS RESULTED IN HYPERGLYCEMIA. PATIENT WOKE UP DURING THE NIGHT OF (B)(6) 2011, AND SHE FELT BAD AND VOMITED. SHE REALIZED SHE HAD ELEVATED BLOOD GLUCOSE (VALUE NOT PROVIDED) AND DELIVERED A CORRECTION BOLUS. BLOOD GLUCOSE DID NOT DECREASE. PATIENT CHANGED THE INFUSION SET AND ATTEMPTED TO DELIVER ADDITIONAL BOLUSES. BLOOD GLUCOSE ELEVATED ABOVE 600 MG/DL. PATIENT THEN PROGRAMMED A QUICK BOLUS. INFUSION DEVICE CONFIRMED THE EXACT AMOUNT BY PROVIDING BEEPS AND VIBRATION, BUT THE BOLUS DID NOT COUNT DOWN AS NORMAL AND THE DISPLAY RETURNED TO THE BASAL RATE. INFUSION CANNULA WAS NOT BENT, AND BLOOD GLUCOSE WAS WITHIN HER TARGET RANGE WHEN SHE WENT TO BED PRIOR TO THE EVENT. PATIENT SWITCHED TO HER BACKUP INFUSION DEVICE AND BLOOD GLUCOSE SLOWLY DECREASED. BY THE AFTERNOON, BLOOD GLUCOSE WAS WITHIN HER TARGET RANGE. 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. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    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