BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6044101 · Received October 20, 2016

    Report

    Report Number
    2032227-2016-33280
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 29, 2016
    Report Date
    November 2, 2016
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE BOLUS WIZARD FUNCTIONED PROPERLY PER BOLUS WIZARD SAMPLE IN THE USER GUIDE. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF ISSUES WITH THEIR INSULIN PUMP. THE CUSTOMER STATES THEY HAD ISSUES WITH HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATES THEY HAD PREVIOUSLY TROUBLESHOT BUT THE ISSUES PERSIST. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 293MG/DL. THE CUSTOMER BELIEVED THE ISSUES WERE WITH THE BOLUS WIZARD. THE CUSTOMER DECLINED TO TROUBLESHOOT AND REQUESTED THE PUMP BE REPLACED. THE CUSTOMER WAS ADVISED THE PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694954 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR