BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201336 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42889
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. SEE MANUFACTURE REPORT NUMBER 2032227-2014-41728.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS HAVING HIGH AND LOWS ALL DAY. CUSTOMER STATED SHE HAD KIDNEY PAINS, NUMBNESS IN HER HANDS, BLURRY VISION THAT GOTTEN WORSE. CUSTOMER WAS ADVISED TO SEE HER DOCTOR AND GO TO THE HOSPITAL BECAUSE SHE WAS FEELING SICK FROM KETONES. CUSTOMER WAS ADVISED TO CALL US AFTER HOSPITALIZATION TO DOCUMENT AND POSSIBLY DOCUMENT TROUBLESHOOTING. CUSTOMER'S BLOOD GLUCOSE WAS 257 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683162 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR