BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2039951 · Received March 9, 2011

    Report

    Report Number
    2183996-2011-00482
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 15, 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 HAVING ELEVATED BLOOD GLUCOSE CONCERNS SINCE (B)(6) 2011. PT STATED, SHE WENT TO THE HOSPITAL AND THE DIABETES NURSE CHECKED HER INFUSION DEVICE AND BASAL RATE. PT REPORTED, THE INFUSION DEVICE WORKS CORRECTLY AND SHE WAS NOT HOSPITALIZED. PT STATED, THE INFUSION DEVICE HAS NOT GIVEN ANY ALARM OR ERROR MESSAGE. PT'S NORMAL BLOOD GLUCOSE IS AROUND 10-11 MMOL/L (180-198 MG/DL). PT STATED, THE LAST FEW DAYS HER BLOOD GLUCOSE HAS BEEN BETWEEN 25-32 MMOL/L (450-576 MG/DL). PT REPORTED, HER BLOOD GLUCOSE ONLY GOES DOWN WHEN SHE USES THE INSULIN PEN. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 72 YR INSULIN INFUSION SET| INSULIN