BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2990658 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91605
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 26MG/DL. THE MOTHER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE DROPPED LOW TWICE, FELL, AND BUSTED TWO FRONT TEETH. THE CALLER STATED THAT THE DOCTOR SAW THE INSULIN PUMP ALLOWED THE CUSTOMER TO BOLUS 18.0 UNITS TWICE. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. THE TIME AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR, BAD BATTERY, AND BATTERY OUT ALARMS. THE CUSTOMER STATED THAT HE HAD X-RAYS DONE AT THE HOSPITAL AND DENTAL OFFICE, BUT SHE WAS NOT WEARING THE INSULIN PUMP. ASSISTED THE MOTHER TO RUN THE DISPLACEMENT TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94025 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization