BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160670 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94575
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 15MG/DL A FEW WEEKS AGO. THE CUSTOMER STATED THAT SHE HAS CHANGED THE CARBOHYDRATE RATIOS, AND ATTEMPTS EATING A BETTER SNACK, BUT NOTHING HAS HELPED. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP, AND HER BLOOD GLUCOSE WAS 113MG/DL. THE CALLER STATED THAT THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CUSTOMER MENTIONED THAT THE MOST RECENT INFUSION SET CHANGE WAS ON (B)(6) 2013. REVIEWED THE PROGRAMMING AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE CUSTOMER STATED THAT SHE TOOK OFF THE DEVICE WHILE HAVING AN X-RAY, BUT IT WAS STILL IN THE X-RAY ROOM. THE DISPLACEMENT TEST WAS PERFORMED AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259561 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization