BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2233958 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82802
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD 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 CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA. THE BLOOD GLUCOSE READING WAS 351 MG/DL. IT WAS STATED THAT THE EVENTS LEADING THE CUSTOMER'S ADMISSION WAS VOMITING, NAUSEA, AND KETONES. TROUBLESHOOTING WAS DECLINED. THE CALL WAS TRANSFERRED TO THE FATHER, AND HE STATED THAT THE CUSTOMER WAS FINE BEFORE BEDTIME. THE CUSTOMER WOKE UP VOMITING, AND HIS GLUCOSE LEVEL WAS 354 MG/DL. THE FATHER STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST TEN HOURS. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP AND 8.0 UNITS OF INSULIN THRU AN INSULIN DRIP. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. THE FIXED PRIME TEST WAS NOT PERFORMED BECAUSE SUPPLIES WERE NOT AVAILABLE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization