BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4000321 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-92806
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 CALLED REPORTING A HIGH BLOOD GLUCOSE EVENT. SHE SAID ON (B)(6) 2014, HER BLOOD GLUCOSE WAS 599 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING HER INSULIN PUMP BECAUSE SHE KNEW WHY HER BLOOD GLUCOSE WAS SO HIGH. SHE STATED, SHE WAS AT A CELEBRATION AND WAS EATING TOO MUCH JUNK. SHE CONTACTED HER DOCTOR AND HE WAS ABLE TO TREAT HER. CUSTOMER HAS NOT CHECKED HER BLOOD GLUCOSE TODAY YET. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477159 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 61 YR Hospitalization