BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150354 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35036
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    August 9, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED NO DELIVERY ALARMS OR MOTOR ERROR ALARMS NOTED. UNIT PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION, PRIME, OCCLUSION, EXCESSIVE NO DELIVERY AND MOTOR TESTS. CRACKED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BEEN RETURNING MOTOR ERROR ALARMS AND NO DELIVERY ALARMS FOR A MONTH LEADING UP TO THE CALL. CUSTOMER REPORTED BEING OFF OF THE INSULIN PUMP FOR APPROXIMATELY ONE MONTH AND TREATING WITH MANUAL INJECTIONS DURING THAT TIME. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARMS. BLOOD GLUCOSE LEVEL WAS 271 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629814 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR