BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3041704 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92415
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING THE BASAL OR BOLUS CORRECTLY, WHICH CAUSED HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER WITH PROGRAMMING A BOLUS AND IT WAS RECORDED IN THE BOLUS HISTORY. HOWEVER, THE CUSTOMER SAW ONLY DROPS OF INSULIN EXITING FROM THE INFUSION SET. THE CUSTOMER STATED THAT HE NOTICED THE ISSUE WHEN HIS BLOOD GLUCOSE WENT OVER 600MG/DL, AND HE TOOK SEVERAL INJECTIONS TO LOWER HIS GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143081 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR