BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945667 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04396
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE OF 144 MG/DL. CUSTOMER STATED THAT SHE WAS HAVING MULTIPLE PROBLEM, CUSTOMER STATED THAT HER INSULIN PUMP SCREEN IS CRACK, THE INFUSION SET ADHESIVE WAS NOT STICKING, SENSORS WAS NOT CONNECTING TO THE INSULIN PUMP AND WAS GETTING WEAK SIGNAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424532 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR UNOMEDICAL INSULIN INFUSION SET