BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190453 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41274
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) 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 HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP HAD AN ABSENCE OF NO DELIVERY ALARM WHEN THERE WAS A BENT INFUSION SET CANNULA. THE BLOOD GLUCOSE READING WAS 381 MG/DL. UNABLE TO TROUBLESHOOT, SINCE THE CUSTOMER STATED THAT SHE HAD ALREADY CHANGED THE INFUSION SET AND NO TUBING CLAMPS WERE AVAILABLE. ADVISED THE CUSTOMER THAT, BECAUSE OF THE OFF LABEL INSERTION OF THE INFUSION SET 4 TO 5 INCHES AWAY FROM THE NAVEL, THE INSULIN PUMP WAS DELIVERING INSULIN BUT THE ABSORPTION RATE WAS SEVERELY REDUCED, EXPLAINING THE ABSENCE OF NO DELIVERY ALARM AND HIGH BLOOD GLUCOSE. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN. SHE DECLINED BEING SENT REPLACEMENT SUPPLIES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667785 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR