BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4160182 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25962
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, AND BASIC OCCLUSION TEST. THE DEVICE WAS RECEIVED STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE NOT DETECTED DURING TESTING. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE PUERTO RICO MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP ALARMED MOTOR ERROR. DURING TROUBLESHOOTING, CUSTOMER STATED THAT THEY DO NOT USE THE SENSOR FEATURE AND WAS UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THEY DID NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS EXPOSED TO MOISTURE. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 157 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581395 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR