BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182798 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02559
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 2, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM WITH A HIGH BLOOD GLUCOSE OF 471 MG/DL. IT WAS STATED THAT THE CUSTOMER FELT LIGHT HEADED AND WEAK. IT WAS ALSO STATED THAT THE INSULIN PUMP HAD GIVEN A BUTTON ERROR ALARM THAT COULD NOT BE CLEARED. THE CUSTOMER CHANGED THE BATTERY, BUT THAT DID NOT SOLVE THE ISSUE. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282344 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization