BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841867 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02827
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WAS TAKEN TO THE EMERGENCY ROOM AND WAS TREATED AND RELEASED. THE BLOOD GLUCOSE READING WAS 250 MG/DL. CUSTOMER STATED THAT SHE ALSO WENT TO THE EMERGENCY ROOM BECAUSE SHE DID NOT HAVE A BACKUP PLAN. CUSTOMER ALSO STATED THAT HER GLUCOSE METER WAS NOT WORKING CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319107 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization