BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3122944 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-02017
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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

    THE CUSTOMER CALLED TO REPORT THAT THE PARAMEDICS WERE CALLED THIS MORNING DUE TO LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE SENSOR AND BOLUS INFORMATION, AND FOUND THAT THE CUSTOMER DELIVERED A 3.0 UNIT BOLUS AT 3:54 AM. THE CUSTOMER STATED THAT HE DELIVERED THE BOLUSED BASED ON THE SENSOR GLUCOSE READING. THE CUSTOMER DID NOT CHECK HIS BLOOD GLUCOSE READING PRIOR TO DELIVERING THE BOLUS. FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. FOUND THAT THE INSULIN PUMP AS WORKING AS DESIGNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224097 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention