BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6182320 · Received December 16, 2016

    Report

    Report Number
    2032227-2016-50367
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 19, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 471 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE WAS 91 MG/DL AT THE TIME OF CALL. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE BY BOLUS. THE CUSTOMER ALSO REPORTED THAT THEY HAD LOW BLOOD GLUCOSE AROUND 50 MG/DL. THE CUSTOMER STATED THAT THEY DELIVERED MORE INSULIN. THE CUSTOMER STATED THAT THEY TREATED THE LOW BLOOD GLUCOSE WITH FOOD. TROUBLESHOOTING WAS DONE FOR LOW BLOOD GLUCOSE. THE CUSTOMER MENTIONED THAT THERE WAS A POSSIBILITY THAT THE INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD. THE CUSTOMER STATED THAT THE PROGRAMMING ON THE INSULIN PUMP WAS INACCURATE. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831993 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other