BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022015 · Received March 26, 2013

    Report

    Report Number
    2032227-2013-01154
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REPORTED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS, HEADACHE, DEHYDRATION AND THIRST. THE CUSTOMER ALSO STATED SHE WAS LETHARGIC AND UNABLE TO SWALLOW. THE CUSTOMER THAN STATED THAT SHE WAS HOSPITALIZED TWICE DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT KNOW THE DATES OF THE EVENTS, BUT REPORTED BLOOD GLUCOSE LEVELS OF 500 AND 600 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT SHE WAS TOLD BY HER HCP THAT SHE HAD AN INFECTION, WHICH MAY HAVE CONTRIBUTED TO THE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WOULD BE WORKING WITH HER HCP ON ADJUSTING THE BASAL RATES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123152 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization