BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4130109 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24518
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER, LOW BATTERY. OR WEAK BATTERY ALARMS WERE NOTED. THE INSULIN PUMP ALARMED FOR A BUTTON ERROR DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY OR MOTOR. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND NO DELIVERY ALARM TESTS. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER GETTING WET THE INSULIN PUMP ALARMED BUTTON ERROR, WHICH COULD NOT BE CLEARED DUE TO THE UNRESPONSIVE BUTTONS. THE CUSTOMER REMOVED AND REINSERTED THE SAME BATTERY INTO THE INSULIN PUMP, AND THE DEVICE ALARMED WEAK BATTERY, AFTER WHICH THE CUSTOMER INSERTED A NEW BATTERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 301 MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE EARLIER SO THEY HAD A SNACK BAR AND JUICE, BUT THEY DELIVERED A BOLUS ONLY FOR THE SNACK BAR AND NOT THE JUICE. THE CUSTOMER DID NOT HAVE A BACKUP PLAN. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579749 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR