BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982222 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90142
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP MONITORED IN 50C OVEN FOR SEVERAL DAYS AND NO BLANK OR BLACK DISPLAY NOTED. THE INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO DAMAGE FOUND ON THE LCD ISOLATION TAPE NOTED. HOWEVER, MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, VIBRATOR AND BATTERY TUBE ASSEMBLY. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING HER INSULIN PUMP ALARMED LOW BATTERY AND THEN WENT BLANK. THE SCREEN HAS HAD A BLACK SQUARE ON IT SINCE LAST NIGHT. CUSTOMER'S BLOOD GLUCOSE IS 500 MG/DL. HE TREATED WITH A MANUAL INJECTION. THE DEVICE WAS NOT EXPOSED TO EXTREME TEMPERATURES OR SUNLIGHT. CUSTOMER WAS AT THE LAKE YESTERDAY, BUT THE DEVICE WAS ON HER HIP AND NOT EXPOSED TO DIRECT SUNLIGHT. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457357 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention