BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3073702 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-92703
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    IT WAS REPORTED THAT THE EXPERIENCED HIGH BLOOD GLUCOSE OF 454 MG/DL, DURING THE EARLY MORNING. CUSTOMER STATED THAT INSULIN PUMP WAS EMPTY. CUSTOMER REPORTS HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE LEVEL OF OVER 1000 MG/DL. CUSTOMER STATED THAT HE COULD NOT GET OUT OF BED AND AN AMBULANCE WAS CALLED. DURING TROUBLESHOOTING, THE TIME AND DATE ARE INCORRECT. ASSISTED CUSTOMER WITH CORRECTING TIME AND DATE. CHECKED ALARM HISTORY, FOUND NO DELIVERY AND LOW RESERVOIR. MANUAL PRIME AND REWIND, FOUND OK. CUSTOMER STATED CONCERN REGARDING BENT CANNULA. ADVISED CUSTOMER ABOUT INSERTING INFUSION SET INTO MUSCLE AND SCAR TISSUE. INSULIN PUMP IS WORKING AS DESIGNED. NOTHING FURTHER WS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175459 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization