BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4073248 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18326
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    July 19, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DESC OF EVENT CONTD: XPOSED TO A STRONG MAGNETIC FIELD OR MRI. * FOUND: NO. * ADV THE CUSTOMER TO DISCONNECT FROM THE PUMP. * INQUIRED IF THE CUSTOMER USES THE SENSOR FEATURE ON THE PUMP. FOUND * CUSTOMER DOES NOT USE THE SENSOR FEATURE. * CUSTOMER STATES THEY ARE ABLE TO REWIND THE PUMP. * ADV THE CUSTOMER THE PUMP WILL NEED TO BE REPLACED. * ADV THE CUSTOMER TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP * PLAN PER HCP'S INSTRUCTION. * ADV THE CUSTOMER TO RETRIEVE THEIR PUMP SETTINGS. * ADV THE CUSTOMER TO RETURN THE PUMP WITH THE BATTERY AND ZERO OUT THE * BASAL RATES. * EXPLAINED THE RPL POLICY. * EXPLAINED THE INTERACTION AFTERCARE EMAIL. * * INITIAL NOTES: CUSTOMER CALLED IN AND STATED SHE WAS ON VACATION AND SHE * JUST GOT BACK. HER PUMP DID A MOTOR ERROR , BUT SHE THOUGHT IT WAS OK. * THE BIGGER PROBLEM, THERE IS A CRACK AND PARTS OF HAVE FALLEN OFF. * PATIENT'S BG: DOES NOT REMEMBER. * CUSTOMER STATES THE PHYSICAL DAMAGE TO THE PUMP IS: ON THE BATTERY * COMPARTMENT AT THE CIRCLE RIDGE, THE PLASTIC IS OFF AND SHE CAN ACTUALLY * RING UNDERNEATH. . * INQUIRED IF THE CUSTOMER IS AWARE OF HOW THE DAMAGE OCCURRED. FOUND: * NORMAL WEAR AND TEAR. * ADV THE CUSTOMER THE PUMP WILL NEED TO BE REPLACED. * ADV THE CUSTOMER TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP * PLAN PER HCP'S INSTRUCTION. * EXPLAINED THE RPL POLICY. * EXPLAINED THE INTERACTION AFTERCARE EMAIL. * * ADDITIONAL NOTES: * 2 OR 3 WEEKS AGO, SHE NOTICED THE CRACKS ON THE PUMP. * * SHIP: 1 PUMP / RETURN: 1 PUMP. 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).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S FATHER THAT THEIR INSULIN PUMP WAS ALARMING MOTOR ERROR AND WAS DAMAGED. CUSTOMER STATED THE DAMAGE IS LOCATED ON THE BATTERY COMPARTMENT WITH LARGE PORTIONS MISSING. DURING TROUBLESHOOTING, CUSTOMER STATED THAT THEY DO NOT USE THE SENSOR FEATURE AND WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553970 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR