BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4244041 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50347
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 STOPPED WORKING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL AT THE TIME OF THE EVENT BUT HIS BLOOD GLUCOSE LEVEL WAS 131 MG/DL BEFORE BREAKFAST AND 248 MG/DL AFTER BREAKFAST. HE NOTICED THAT THE INSULIN PUMP STOPPED VIBRATING WHEN IT WOULD VIBRATE ALL DAY. THE CUSTOMER ALSO REPORTED THAT HE BELIEVED THE INSULIN PUMP WAS NOT DELIVERING INSULIN BECAUSE OF HIS HIGH BLOOD GLUCOSE LEVEL. HE TREATED HIS HIGH BLOOD GLUCOSE LEVEL WITH A MANUAL INJECTION. THE CUSTOMER WAS ADVISED TO MONITOR HIS INSULIN PUMP. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725846 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR