BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170419 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37934
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A FAILED BATTERY TEST DUE TO A CORRODED BATTERY TUBE. NO WEAK BATTERY ALARM OR BLANK DISPLAY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CORRODED BATTERY CAP CONTACT, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND A BROKEN RESERVOIR TUBE LIP.

    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 REPORTED HE HAD RECEIVED A BLANK DISPLAY. HE STATED THE BLANK DISPLAY FOLLOWED A LOW BATTERY AND FAILED BATTERY TEST. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING DID NOT FIND ANY DAMAGE TO THE BATTERY COMPARTMENT OF THE INSULIN PUMP. THE CUSTOMER CONTINUED TO RECEIVE A BLANK DISPLAY AFTER REPLACING IT WITH NEW BATTERIES. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651315 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR