BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150078 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34932
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. (B)(4)

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED, ALL OPERATING CURRENTS TESTED WITHIN SPECIFICATION RANGE. NO UNEXPECTED OFF NO POWER ALARMS NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES FOR CUSTOMER'S INSULIN PUMP ARE LASTING ABOUT TWO DAYS. CUSTOMER RECEIVED AN OFF NO POWER ALARM. CUSTOMER CHANGED THE BATTERY ON (B)(6) 2014. HIS BLOOD GLUCOSE IS 149 MG/DL. CUSTOMER USES RAYOVAC BATTERIES. HE DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. THE DEVICE HAS BEEN DROPPED. THE BATTERY CAP IS NOT LOOSE OR DAMAGED. CUSTOMER STATED THIS IS THE SECOND OFF NO POWER ALERT WITHOUT A LOW BATTERY WARNING. THE DEVICE ALSO HAS A CRACK IN THE UPPER RIGHT AND LEFT CORNERS OF THE SCREEN. 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
    626924 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR