BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193029 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41774
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE ESCAPE BUTTON DUE TO CORRODED KEYPAD TRACE. UNABLE TO PERFORM DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S FATHER THAT THE CUSTOMER HAD A SMALL CRACK AROUND THE BATTERY CAP AND AN UNRESPONSIVE KEYPAD ON THE INSULIN PUMP. CUSTOMER'S FATHER STATED THAT HE TRIED TO BOLUS AND IT WILL NOT LET HIM BOLUS. THE INSULIN PUMP IS WITH HIS DAUGHTER AT SCHOOL. CUSTOMER'S FATHER WAS UNABLE TO TROUBLESHOOT FOR KEYPAD ISSUES, BUT PUMP WILL BE REPLACED DUE TO THE CRACK. CUSTOMER HAD A SEIZURE AND THE PUMP MAY HAVE CRACKED WHEN SHE FELL TO THE FLOOR. CUSTOMER'S DAD IS NOT SURE IF IT IS RELATED TO BLOOD GLUCOSE LEVELS, BUT HIS ASSUMPTION WAS THAT HIS DAUGHTER'S BLOOD GLUCOSE LEVELS WERE TOO LOW. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671403 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 17 YR