BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132181 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31002
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 THAT THE INSULIN PUMP WENT BLANK AND DOES NOT ASK FOR CARBS AFTER PRESSING SET BOLUS. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE READINGS OF 43 MG/DL AND HAS TREATED WITH FOOD. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTING APPEARED TO BE NORMAL. DISPLACEMENT TEST WAS PERFORMED AND PASSED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612498 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR