BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3110016 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01903
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    THE CUSTOMER CALLED FROM THE HOSPITAL FOR ASSISTANCE WITH THE BASAL RATE SETTINGS. THE CUSTOMER STATED THAT HER DOCTOR TOOK HER OFF THE INSULIN PUMP DUE TO LOW BLOOD GLUCOSE LEVELS, BUT IS NOW PUTTING HER BACK ON. THE CUSTOMER STATED THAT SHE WAS IN THE HOSPITAL DUE TO AN INFECTION UNRELATED TO HER DIABETES. HOWEVER, SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE WHILE IN THE HOSPITAL, AND WAS TREATED WITH AN INJECTION. ASSISTED THE CUSTOMER WITH PART OF THE BASAL RATE SETTINGS AS ONE OF THE RECOMMENDED RATES COULD NOT BE PROGRAMMED. ADVISED TO DOUBLE CHECK THE SETTINGS WITH THE HCP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210400 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization