BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4040653 · Received August 27, 2014

    Report

    Report Number
    3004209178-2014-98034
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE DRIVE SUPPORT DISK. NO ALARM FOR THE LOOSE DRIVE SUPPORT DISK DUE TO THE MOTOR ERROR ALARM. THE MOTOR WAS TESTED OUTSIDE OF THE INSULIN PUMP AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT A DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE RECEIVED AN ALARM ON THE INSULIN PUMP DURING THE REWIND/PRIME. DURING TROUBLESHOOT; CUSTOMER WAS INSTRUCTED TO REMOVE THE RESERVOIR AND REWIND THE INSULIN PUMP AND IT ALARMED AGAIN. BLOOD GLUCOSE LEVEL WAS 87 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521782 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS A8723NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR