BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182861 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39996
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST, AND OFF NO POWER TEST. NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND A CRACKED CASE AT A RESERVOIR TUBE WINDOW CORNER.

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLANK DISLAY. THE BLOOD GLUCOSE READING WAS NOT KNOWN. HE STATED THAT THE INSULIN PUMP SHOWED NO SIGNS OF DAMAGE AND HAD NOT BEEN DROPPED, BUMPED OR EXPOSED TO MOISTURE. HE STATED THAT THE BATTERY CAP CONTACTS WERE NOT MISSING OR DAMAGED AND THAT THE BATTERY COMPARTMENT AND SPRING WERE NOT DAMAGED OR CORRODED. CUSTOMER WAS UNABLE TO REPLACE THE BATTERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661983 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR