BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933527 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03832
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAS NOT BEEN WORKING. CUSTOMER HAD HIGH BLOOD GLUCOSE, WHICH WAS 500MG/DL. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH A SYRINGE. CUSTOMER'S BLOOD GLUCOSE LOWERED TO 383MG/DL. CUSTOMER STATED DURING THE NIGHT, THE BLOOD GLUCOSE READING WAS 62MG/DL. CUSTOMER STATED INSULIN PUMP AND INSULIN IS WORKING WELL. CUSTOMER STATED THEY HAVE A BACKUP PLAN. CUSTOMER FOUND AIR BUBBLES IN TUBING AREA. CUSTOMER PRIMED AND AIR BUBBLES ARE NO LONGER VISIBLE. THE BLOOD GLUCOSE READING WAS 199MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410701 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR