BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103408 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25267
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. NO UNEXPECTED BATTERY OUT LIMIT ALARMS NOTED. THE DEVICE WAS RECEIVED WITH UNRESPONSIVE DOWN ARROW BUTTON DUE TO CORRODED KEYPAD TRACES. THE UNIT WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, RESERVOIR TUBE AND BATTERY TUBE THREADS, MINOR SCRATCHED DISPLAY WINDOW, MISSING END CAP STICKER, BROKEN RESERVOIR TUBE LIP, AND MISSING RESERVOIR TUBE LIP O-RING.

    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 THAT THE BUTTONS ON THE INSULIN PUMP BECAME UNRESPONSIVE AFTER A BATTERY CHANGE BUT THAT THE TIME DID ADVANCE. THE BLOOD GLUCOSE READING WAS 107 MG/DL. SHE ALSO RECEIVED A BATTERY OUT LIMIT ALARM AFTER THE BATTERY CHANGE AND STATED THAT THE BATTERIES HAD BEEN OUT OF THE INSULIN PUMP FOR AN EXTENDED PERIOD OF TIME. SHE STATED THAT LEADING UP TO THE KEYPAD ISSUES, THE BUTTONS HAD BECOME HARDER TO PRESS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584735 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR