BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193038 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41776
    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
    OH
    Reporter Occupation
    PATIENT

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BATTERY OUT LIMIT ALARM OR FAILED BATTERY TEST ALARM COULD BE VERIFIED DUE TO THE UNRESPONSIVE BUTTONS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED DISPLAY WINDOW, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A FAILED BATTERY TEST ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 217 MG/DL. CUSTOMER STATED THAT HE PUT A BATTERY INTO THE PUMP AND HE RECEIVED A FAILED BATTERY TEST ALARM. CUSTOMER WAS UNABLE TO GET THE BUTTONS TO RESPOND. CUSTOMER ALSO NOTICED A CRACK IN THE PUMP TODAY. THE CRACK IS NEAR THE RESERVOIR COMPARTMENT AND GOES INTO THE SCREEN. CUSTOMER WAS UNABLE TO FINISH TROUBLESHOOTING BECAUSE AFTER INSERTING A NEW BATTERY, THE BUTTONS WERE NOT RESPONDING TO ALLOW THE ALARM TO BE CLEARED. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672638 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR