BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894866 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03353
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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 CALLED IN TO REPORT HIGH BLOOD GLUCOSE OVER THE COURSE OF MANY DAYS. THE BLOOD GLUCOSE READING AT THOSE TIMES WERE 600 MG/DL. THE CUSTOMER ALSO MENTIONED THAT SHE WAS HAVING TROUBLE GIVING BOLUS ON THE INSULIN PUMP AND HEARING THE ALARMS. THE CURRENT BLOOD GLUCOSE READING IS 281 MG/DL. THE CUSTOMER TREATED WITH BOLUS. CUSTOMER DID NOT FEEL WELL ENOUGH TO TROUBLESHOOT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370339 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR