BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241201 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50021
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 12, 2014
    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

    THIS MDR RELATED TO THE PUERTO RICO 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 CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF OVER 400 MG/DL; TREATED WITH MANUAL INSULIN INJECTION. CUSTOMER STATED HE CHANGED THE INFUSION SET AND RESERVOIR TWICE AND ISSUE PERSISTED. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. THE TUBING HAS NO AIR BUBBLES AND NO INSULIN LEAK WAS FOUND. INSULIN DID EXIT THE TUBING WITH MANUAL PRIME. TIME, DATE AND BOLUS WIZARD ARE CORRECT. CUSTOMER STATED THAT SOME OF THE BASAL RATES WERE CHANGED RECENTLY BY THE DOCTOR. LAST BLOOD GLUCOSE VALUE WAS 428 MG/DL; CUSTOMER FELT VERY SICK. CUSTOMER REMOVED THE INFUSION SET AND THE CANNULA WAS NOT BENT OR OCCLUDED. THE HIGH PRESSURE TEST WAS NOT PERFORMED AS THE CUSTOMER DID NOT HAVE THE TUBING CLAMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724036 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 Required Intervention