BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831239 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84997
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    CUSTOMER REPORTED HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. PATIENT'S BLOOD GLUCOSE READING WAS IN THE RANGE OF 20 MG/DL. PATIENT STATED THAT SHE RECEIVED A SHOT THAT DAY FOR HIGH BLOOD GLUCOSE AND BOLUSED FOR WHAT SHE ATE AS WELL. TROUBLESHOOTING DID NOT REVEAL ANY MALFUNCTIONS. ADVISED CUSTOMER TO KEEP MONITORING THE PUMP AND TO SPEAK TO HER HEALTH CARE PROFESSIONAL ABOUT LOW BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308780 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 52 YR Hospitalization