BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972338 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05147
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 A LOW BLOOD GLUCOSE WHILE HE WAS DRIVING. CUSTOMER STATED THAT HE CHECKED THE INSULIN PUMP AND NOTICED MOST OF THE INSULIN WAS GONE. THE BLOOD GLUCOSE READING WAS 57 MG/DL AT THE TIME OF HOSPITALIZATION AND 110 MG/DL AT THE TIME OF THE REPORT. CUSTOMER WAS TREATED WITH LIQUID GLUCOSE AND FOOD. HE STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL AND RECESSED. CUSTOMER WAS IN THE HOSPITAL DUE TO A CAR ACCIDENT IN WHICH HE WAS THE DRIVER. THE PROGRAMMING WAS REVIEWED AND IT WAS FOUND THAT 18 UNITS OF INSULIN WAS DELIVERED TO THE CUSTOMER WITHIN AN HOUR AND 40 MINUTES. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448578 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization