BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4073261 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18341
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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) SITE, PER VARIANCE 5. 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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE READING OF 400 MG/DL, WHICH HE TREATED WITH THE INSULIN PUMP. THE CUSTOMER STATED THAT THERE APPEARED TO BE AN OPEN CIRCLE ON THE DISPLAY SCREEN AND HE WAS UNSURE WHY IT WAS VISIBLE THERE. EXPLAINED THAT THIS WAS DUE TO THE TEMP BASAL HAVING BEEN PROGRAMMED; THE CUSTOMER UNDERSTOOD. HE COMPLAINED OF EXCESSIVE THIRST, EXCESSIVE URINATION, DRY MOUTH, FRUITY BREATH, AND IRRITABILITY. UPON TROUBLESHOOTING, IT WAS FOUND THAT INSULIN DID EXIT FROM THE TUBING DURING A MANUAL PRIME AND NO LEAK WAS NOTED. UNABLE TO COMPLETE TROUBLESHOOT DUE TO LACK OF TUBING CLAMPS. ADVISED THAT THE TUBING CLAMP WOULD BE SENT FOR COMPLETION OF TROUBLESHOOT. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR, AND INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554777 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR