BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3842355 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02651
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT HE WAS IN THE HOSPITAL FOR LOW OXYGEN LEVELS. THE CUSTOMER SAID THAT HE HAD A HARD TIME SPEAKING AND THAT WAS THE REASON HE WENT. THE CUSTOMER SAID HE WAS WEARING HIS INSULIN PUMP AT THE TIME OF THE VISIT AND WAS TRYING TO ISSUE A BOLUS FOR HIS BREAKFAST MEAL. THE ROOM WAS TOO DARK AND THE CUSTOMER PUSHED THE WRONG BUTTONS AND NOW HE HAS A BLOOD GLUCOSE LEVEL OF 535 MG/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320673 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization