BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2170867 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01885
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    December 20, 2010
    Report Date
    June 8, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. PT STARTED USING THIS INFUSION DEVICE IN (B)(6) AND HAS EXPERIENCED ELEVATED BLOOD GLUCOSE SINCE THE (B)(6) 2010. SHE HAS USED TWO TYPES OF INSULIN, BUT BLOOD GLUCOSE REMAINED ELEVATED. INFUSION SET IS USED PER SPEC, AND THE INFUSION DEVICE WAS NOT EXPOSED TO ELECTROMAGNETIC FIELDS. PT WAS NOT EXPERIENCING ADD'L STRESS OR INCREASED ACTIVITY, AND THERE WERE NO CHANGES TO HER HEALTH OR MEDICATION. AT ONE TIME, THE INFUSION DEVICE DISPLAYED AN E4 OCCLUSION ERROR AND PT CHANGED THE INFUSION SET. BASAL RATES ARE PROGRAMMED CORRECTLY AND HAVE BEEN INCREASED SEVERAL TIMES BY HER DIABETES NURSE. NORMAL BLOOD GLUCOSE IS 5 - 10 MMOL/L (90 - 180 MG/DL). BLOOD GLUCOSE RANGED FROM 6.2 - 29.8 MMOL/L (111.6 - 536.4 MG/DL) ON (B)(6) 2011 AND FROM 4.2 - 17.9 MMOL/L (75.6 - 322.2 MG/DL) ON (B)(6) 2011. SHE DELIVERED INSULIN VIA INFUSION DEVICE AND PEN TO CORRECT HYPERGLYCEMIA. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. SINCE CHANGING TO THE REPLACEMENT INFUSION DEVICE, HER BLOOD GLUCOSE LEVELS ARE AROUND 10 MMOL/L (180 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR INSULIN| INSULIN INFUSION SET