BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103493 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26382
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 1, 2013
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE CUSTOMER WAS TREATED FOR LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THE LOW BLOOD GLUCOSE WAS CAUSED BY THE INSULIN PUMP OVER DELIVERING BOLUS. CUSTOMER STATED IT DELIVERED ABOUT 30 INSULIN UNITS. SHE STATED ONCE SHE NOTICED IT, SHE WENT TO HER FAMILIES HOUSE TO BE TREATED WITH GLUCAGON SHOT. BLOOD GLUCOSE VALUE WAS 20 MG/DL. THE DRIVE SUPPORT CAP APPEARS NORMAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583692 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAP A000168707

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention