BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2792186 · Received October 11, 2012

    Report

    Report Number
    2183996-2012-01537
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED THAT HER BLOOD GLUCOSE LEVEL WAS HI AND SHE WAS NOT ABLE TO GET IT TO GO DOWN. SHE HAD CONCERNS ABOUT WHETHER OR NOT THE INFUSION DEVICE WAS WORKING PROPERLY AND WANTED TO SWITCH TO HER BACKUP DEVICE. THE PT BOLUSED OVER 60 UNITS OF INSULIN TO BRING HER BLOOD GLUCOSE LEVEL DOWN. AT THE TIME OF REPORT THE PT WAS IN THE HOSP AND HAD BEEN IN THE HOSP SINCE AROUND NOON ON (B)(6) 2012. SHE IS BEING TREATED VIA IV OF INSULIN. THE PT'S INFUSION DEVICE HAS NOT DISPLAYED ANY ERROR MESSAGES. WHEN SHE REMOVED THE INFUSION SET SHE SAW A KINK IN THE CANNULA. THE PT'S BLOOD GLUCOSE LEVEL WENT DOWN TO 100 MG/DL WHILE SHE WS IN THE HOSP. F/U WITH THE PT REVEALED THAT THE PT'S BLOOD GLUCOSE LEVELS HAD RETURNED TO NORMAL. BOTH THE PT AND THE HOSP STAFF THOUGHT THAT IT WAS THE BENT CANNULA CAUSING THE ELEVATED BLOOD GLUCOSE LEVELS. THE PT WAS SENT AN INSERTION DEVICE AS A COURTESY. THE INFUSION SET WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX FPA ROCHE INSULIN DELIVERY SYSTEMS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R GMMI NUMBER, LOT NUMBER AND EXP DATE UNK