BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233735 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48945
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED NO DELIVERY ALARMS FOR ABOUT TWO WEEKS. CUSTOMER STATES ALARM WAS RESOLVED WITH A COMPLETE INFUSION SET CHANGE. CUSTOMER'S BLOOD GLUCOSE DURING CALL WAS 396 MG/DL AND 507 MG/DL. DURING TROUBLESHOOTING CUSTOMER STATES THAT HE MIXED CLOUDY INSULIN WITH CLEAR INSULIN. HE ALSO STATES THAT RESERVOIR APPEARED TO HAVE LEAKED BETWEEN THE FIRST O-RING AND THE SECOND O-RING. LASTLY, CUSTOMER STATES THAT HE HAD A BENT CANNULA. CUSTOMER WAS ADVISED TO REQUEST INFUSION SET WITH SHORTER CANNULA SINCE CUSTOMER IS LEAN. TROUBLESHOOTING COULD NOT BE CONTINUED AS CUSTOMER DID NOT HAVE TUBING CLAMP. CUSTOMER WAS ADVISED TO CALL BACK ONCE HE RECEIVES TUBING CLAMP IN ORDER TO CONTINUE TROUBLESHOOTING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715092 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR