BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3112529 · Received May 14, 2013

    Report

    Report Number
    2032227-2013-01949
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    THE CUSTOMER CALLED TO REPORT A HIGH BLOOD GLUCOSE OF 510 MG/DL. THE CUSTOMER WAS TRYING TO BOLUS, BUT KEPT GETTING A MAX BOLUS EXCEEDED ALARM. ASSISTED THE CUSTOMER WITH THE ALARM. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. FOUND NO DELIVERY ALARMS IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T HAVE A TUBING CLAMP FOR THE HIGH PRESSURE TEST. INSPECTED THE DRIVE SUPPORT CAP, AND THE CUSTOMER STATED IT WAS LOOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212348 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR