BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4203540 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-31668
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED NO DELIVERY OR MOTOR ERROR ALARMS WERE NOTED. HOWEVER, THE DRIVE SUPPORT DISK WAS FOUND SLIGHTLY LOOSE. THE DEVICE HAD CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHED LCD WINDOW.

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED CUSTOMER HAS BEEN GETTING CONTINUAL NO DELIVERY ALARMS THE LAST FEW DAYS. CUSTOMER HAS DONE THREE COMPLETE SET CHANGES, CHANGED OUT THE BATTERY A FEW TIMES, BUT THE ISSUE PERSISTS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. IN TROUBLESHOOTING CUSTOMER DISCONNECTED AND RAN A FIXED PRIME, BUT INSULIN DID NOT EXIT. CUSTOMER WAS ABLE TO MANUALLY PUSH INSULIN THROUGH WITH A PLUNGER. WHEN CUSTOMER TRIED RUNNING A MANUAL PRIME, THE DEVICE ALARMED MOTOR ERROR. 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
    682602 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR