BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6000590 · Received October 5, 2016

    Report

    Report Number
    2032227-2016-27835
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    July 15, 2016
    Report Date
    September 14, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAS BEEN ALARMING NO DELIVERY CONSTANTLY AND THAT HER BLOOD GLUCOSE HAS BEEN IN THE 300 MG/DL AND 400 MG/DL RANGE FOR THE PAST THREE DAYS. SHE WAS ALSO HOSPITALIZED OVER THE WEEKEND DUE TO DIABETIC KETOACIDOSIS. THE PATIENT TREATED VIA MANUAL INSULIN INJECTION. THE CUSTOMER STATED THAT SHE ROTATES HER SITES AND AVOIDS SCAR TISSUE. HER TUBING WAS NOT BENT OR KINKED EITHER. HOWEVER, THE CUSTOMER WAS UNWILLING TO TRY DIFFERENT INFUSION SETS OR CANNULA LENGTHS. THE INSULIN PUMP WILL BE RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652767 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other