BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5132581 · Received October 7, 2015

    Report

    Report Number
    2032227-2015-53906
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 19, 2015
    Report Date
    September 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE READINGS FROM HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 487 MG/DL. THE CUSTOMER STATED THAT HER PUMP IS NOT WORKING PROPERLY BECAUSE HER SUGARS MAY HAVE BEEN HIGH. THE CUSTOMER STATED THAT SHE HAS NOT CONTACTED HER HEALTH CARE PROVIDER REGARDING HER HIGH BLOOD GLUCOSE READINGS. THE CUSTOMER WAS ADVISED TO DETERMINE IF THE CANNULA IS BENT, THE SITE MUST BE REMOVED FROM THE BODY. THE CUSTOMER WAS ADVISED TO REMOVE THE RESERVOIR, REWIND AND REINSERT THE RESERVOIR AND RUN MANUAL PRIME WITH THE CURRENT SET. THE CUSTOMER DECLINED TO TROUBLESHOOT. THE CUSTOMER WILL CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661967 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 53 YR Other