BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210911 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44764
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO A MISSING BATTERY TUBE SPRING. NO OFF NO POWER ERROR COULD BE VERIFIED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND MISSING THE END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS NOT ADVANCING FROM THE BOLUS MENU AND THE CUSTOMER WAS NOT GETTING ANY INSULIN. CUSTOMER STATED THAT THERE WAS A BLACK CIRCLE AND THE BATTERY ICON WAS SHOWING EMPTY. CUSTOMER CHANGED THE BATTERIES AND RECEIVED AN OFF NO POWER ALARM. CUSTOMER DID NOT RECEIVE A LOW BATTERY ALARM PRIOR TO THE OFF NO POWER. CUSTOMER MENTIONED THAT THE SPRING CAME OUT OF THE BATTERY COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE READINGS AT THE TIME OF THE CALL WERE 555 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693511 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR