BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933280 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87024
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION DUE TO A LOOSE AND FLUSH DRIVE SUPPORT DISK. THE ALARM FOR THE LOOSE DRIVE SUPPORT DISK COULD NOT BE VERIFIED DUE TO THE MOTOR ERROR ALARMS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE, RESERVOIR TUBE LIP AND BATTERY TUBE THREADS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED STATING THAT CUSTOMER'S INSULIN PUMP KEEPS ALARMING WHILE SHE IS CHANGING OUT HER INFUSION SET. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 148 MG/DL. INSULIN IS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE DEVICE WAS NOT BUMPED OR DROPPED BEFORE THE ALARM. THE DRIVE SUPPORT CAP APPEARS NORMAL. IT WAS EXPLAINED TO CUSTOMER THAT THE POSSIBLE CAUSE OF THE ALARM WAS THAT DURING SEATING THE FORCE SENSORS DID NOT DETECT THE RESERVOIR. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE ITS USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409356 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR