BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241228 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50082
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE HAS BEEN RECEIVING EXCESSIVE NO DELIVERY ALARMS ON HIS INSULIN PUMP. HIS INFUSION SETS KEEP GETTING TANGLED UP AND PULLING OUT. IN THE LAST COUPLE OF MONTHS, CUSTOMER HAS HAD TO THROW OUT SIX INFUSION SETS DUE TO TANGLES OR PULLING OUT. CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. CUSTOMER WAS ADVISED OF POSSIBLE CAUSES OF NO DELIVERY ALARMS. HE WAS ADVISED OF PROPER INFUSION SET INSERTION AND NO DELIVERY TROUBLESHOOTING METHODS. CUSTOMER WAS ADVISED TO CALL THE NEXT TIME THE NO DELIVERY ALARM OCCURS FOR PROPER TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723378 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR