BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2940019 · Received February 1, 2013

    Report

    Report Number
    2032227-2013-00446
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 500 MG/DL. CUSTOMER STATED THAT HER METER DID NOT READ THE INSULIN PUMP AND BOLUS WAS NOT DELIVERED. SHE STATED THE DELIVERED A BOLUS AGAIN AND IT DID DELIVERED. CUSTOMER ALSO STATED THAT SHE IS NOT REMEMBERING TO BOLUS WHEN SHE NEEDS TO AND MAY HAVE CAUSE THE HIGH BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44264 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization