BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130830 · Received May 24, 2013

    Report

    Report Number
    2032227-2013-02160
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 REPORTED THAT HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS 334 MG/DL. CUSTOMER STATED THAT HIS INFUSION SET CANNULA WAS BENT WHEN IT WAS REMOVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231121 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization