BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103376 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25251
    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 Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD CRACKED LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    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).

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED THAT THE INSULIN PUMP RETURNED A BUTTON ERROR ALARM. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARM. BLOOD GLUCOSE LEVEL WAS 122 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584353 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR