BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5151802 · Received October 15, 2015

    Report

    Report Number
    2032227-2015-56946
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES.NO FROZEN SCREEN NOTED. NO MOISTURE DAMAGE FOUND INSIDE THE INSULIN PUMP. UNABLE TO PERFORM THE OCCLUSION TEST DUE TO BUTTON KEYPAD ANOMALY. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, MINOR SCRATCHED AND CRACKED DISPLAY WINDOW.

    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

    THE CUSTOMER CALLED IN TO REPORT THAT THE INSULIN PUMP'S DISPLAY WAS FROZEN, SO SHE CHANGED THE BATTERY AND THE DEVICE ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 425 MG/DL. THE CUSTOMER TREATED WITH A MANUAL INJECTION. THE DEVICE WAS EXPOSED TO MOISTURE VIA SWEAT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS INFORMED THAT THE DEVICE WOULD BE REPLACED, AND WAS INFORMED TO RETURN THE MALFUNCTIONING DEVICE BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683636 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other