BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3011707 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-91963
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 WITH DIABETES AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 285MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER MENTIONED GETTING NO DELIVERY ALARMS DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT HER LEGS WERE SWOLLEN AND RED, AND HER BLOOD GLUCOSE HAS NOT BEEN HIGH BEFORE. THE CUSTOMER HAS NEUROPATHY, AND SHE IS TAKEN GABAPENTIN MEDICATION. THE CALLER STATED THAT SHE WAS WEARING THE INSULIN PUMP AND WHEN THEY TOOK OFF THE DEVICE HER BLOOD GLUCOSE INCREASED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114657 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization