BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142242 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33364
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS. THERE WERE MINOR SCRATCHES ON THE DISPLAY WINDOW. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE AND THE INSULIN PUMP WOULD NOT POWER ON. THE CUSTOMER'S SYMPTOMS WERE FREQUENT URINATION AND LETHARGY. HER BLOOD GLUCOSE WAS 474 MG/DL, WHICH WAS TREATED WITH INSULIN AT THE HOSPITAL. LEADING UP TO THE HOSPITALIZATION, THE CUSTOMER WAS HAVING DIFFICULTY WITH THE INSULIN PUMP AND COULD NOT GET IT TO WORK. SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED. NO DAMAGE OR CORROSION WAS FOUND IN THE BATTERY COMPARTMENT OR SPRING, AND THE BATTERY CAP CONTACTS WERE NEITHER MISSING NOR DAMAGED. THE DISPLAY DID NOT RETURN WITH A NEW BATTERY. CLEANING THE BATTERY CAP DID NOT RESOLVE THE ISSUE. IT WAS ADVISED FOR THE CUSTOMER TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621841 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization