BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3943049 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87726
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING HIGH BLOOD GLUCOSE LEVELS WHILE WEARING HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 600 MG/DL. SHE HAS TREATED WITH A MANUAL INJECTION. SHE SAID SHE WAS EXPERIENCING DRY MOUTH AND A LACK OF ENERGY. THE DRIVE SUPPORT CAP APPEARS NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED THE TUBING DURING A MANUAL PRIME. THERE WAS NO LEAK. THE DEVICE'S HISTORY IS ACCURATE. THE CANNULA IS NOT BENT OR OCCLUDED. TROUBLE SHOOTING COULD NOT BE COMPLETED BECAUSE CUSTOMER DID NOT HAVE A TUBING CLAMP. CUSTOMER WAS ADVISED OF PROPER SITE AND INFUSION SET METHODS. SHE WAS ADVISED TO CHANGE HER INFUSION SET AND RESERVOIR, AND TREAT ACCORDING TO HER DOCTOR'S INSTRUCTIONS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419327 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR