BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2973069 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-91224
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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 HOSPITAL DUE TO LOW BLOOD GLUCOSE OF 56MG/DL. THE CALLER STATED THAT SHE WAS NOT USING THE INSULIN PUMP WHILE STAYING IN THE HOSPITAL AND THE DOCTOR WANTS TO CHANGE HER BASAL RATE. THE CUSTOMER STATED THAT SHE LOST CONSCIOUSNESS BECAUSE SHE RAN OUT OF INSULIN AND HAD NO BATTERY. INITIALLY, THE CUSTOMER REQUESTED ASSISTANCE WITH PROGRAMMING THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76771 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization