BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210622 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43271
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 472 MG/DL. THE CUSTOMER WOKE UP AT THE TIME OF THE EVENT AND THE INSULIN PUMP WAS NOT TURNED ON. THE CUSTOMER CHANGED THE BATTERIES AND THE INSULIN PUMP WAS STILL NOT FUNCTIONING. HE REPORTED THAT THERE WAS A BLANK DISPLAY ON THE SCREEN. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP AND HE REPORTED THAT THE WAS ALREADY FOLLOWING HIS BACK UP PLAN. TROUBLESHOOTING WAS NOT FULLY COMPLETED AT THE TIME OF THE REPORT. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680657 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other