BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160641 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94572
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 REPORTED BEING IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 527MG/DL. THE CUSTOMER BELIEVES THAT THE INSULIN PUMP WAS NOT GIVING HER ALL THE INSULIN SHE PROGRAMS. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CALLER STATED THAT HER SITE GOT RIPPED OUT OF HER BODY, AND WHILE CHANGING THE INFUSION SET, SHE RECEIVED A NO DELIVERY ALARM. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND MULTIPLE NO DELIVERY ALARMS AND A NO RESERVOIR ALARM. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE CUSTOMER MENTIONED THAT WHEN SHE CHANGED THE SITE, SHE NOTICED THE CANNULA WAS BENT. INSTRUCTED THE CALLER TO REMOVE AND TO REINSERT THE INFUSION SET TO RUN AGAIN THE MANUAL PRIME TEST, AND THE INSULIN PUMP DID NOT ALARM. ADVISED THE CALLER THAT THE DEVICE IS FUNCTIONING AS DESIGNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260562 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 17 YR Hospitalization