BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5304498 · Received December 16, 2015

    Report

    Report Number
    2032227-2015-75426
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 10, 2015
    Report Date
    December 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED A21 DUE TO FAULTY COMPONENT ON THE INTERFACE BOARD. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. NO OFF NO POWER ANOMALY, BATTERY OUT LIMIT ALARMS OR A17 ALARMS NOTED. THE INSULIN PUMP PASSED BASIC OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. NO UNEXPECTED NO DELIVERY ALARMS WERE NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BEEN ALARMING UNEXPECTED RESTART AND EXTERNAL RAM ERROR AND HAS DAH TWO OFF NO POWER ALARMS WITHOUT A LOW BATTERY ALERT. THE ALARM HISTORY SHOWED THREE UNEXPECTED RESTART, TWO RAM ERROR, THREE BATTERY OUT LIMIT AND TWO OFF NO POWER. CUSTOMER STATED THE DEVICE WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. THE INSULIN PUMP WAS NOT DROPPED OR BUMPED AND THE BATTERY CAP IS NOT LOOSE, CRACKED OR DAMAGED. BLOOD GLUCOSE VALUE IS UNKNOWN. CUSTOMER WAS ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830037 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR