BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982368 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90110
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT ALL THE OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE INSULIN PUMP PASSED THE SELF TEST. NO UNEXPECTED LOW BATTERY OR BATTERY OUT LIMIT ALARMS NOTED. NO UNEXPECTED ON AND OFF DISPLAY ANOMALY UNIT NOTED. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, STAINED END CAP STICKER AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP WAS TURNING ON AND OFF AND THE BATTERIES WERE DEPLETING QUICKLY. THE BLOOD GLUCOSE READING WAS 311 MG/DL. THE PATIENT STATED THAT THE BATTERY WAS NOT PREVIOUSLY USED. SHE REPORTED THAT THE INSULIN PUMP HAS TURNED OFF A FEW TIMES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP CAN BE USED UNTIL REPLACEMENT ARRIVES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458472 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 34 YR