BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972320 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88692
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 THE INSULIN PUMP WAS MONITORED FOR 48 HOURS WITH MULTIPLE BASAL RATES. NO BLANK DISPLAY OR REWIND ANOMALY NOTED. ALL OPERATING CURRENTS WERE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY, OFF NO POWER, FAILED BATTERY TEST ALARM OR BATTERY INDICATOR ANOMALY NOTED. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS. NO DAMAGE INSIDE PUMP NOTED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP IS NOT WORKING PROPERLY. THE INSULIN PUMP HAS ALARMED BATTERY FAILED. THE BLOOD GLUCOSE READING IS 129 MG/DL. DURING TROUBLESHOOTING, NO CORROSION OR DAMAGE TO THE SPRING ON BATTERY CAP CONTACTS. CALLER REQUESTED TO HAVE THE INSULIN PUMP REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448550 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR