BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193024 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41768
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH AN INTERMITTENT BUTTON, DUE TO CORRODED KEYPAD TRACES. NO DISPLAY RAMPING ON IT OWN ANOMALY NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, BROKEN RESERVOIR TUBE LIP AND CRACKED BELT CLIP SLOT.

    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 WIFE REPORTED THAT SHE WAS UNABLE TO EXIT THE BOLUS DELIVERY SCREEN. THE WIFE THEN REPORTED THE ACT BUTTON WAS STUCK AND THAT THE INSULIN PUMP WAS SWITCHING FROM THE REWIND COMPLETE SCREEN TO THE BOLUS DELIVERY SCREEN WITHOUT ANY TOUCH FROM THE CUSTOMER. THE CUSTOMER'S BLOOD GLUCOSE WAS 207 MG/DL. THE WIFE COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671987 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 64 YR