BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2944528 · Received February 5, 2013

    Report

    Report Number
    2032227-2013-00467
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL, AND THE CANNULA WAS BENT. THE SYMPTOMS LEADING TO HER ADMISSION WAS VOMITING. THE CUSTOMER CALLED BACK TO REPORT THAT THE INSULIN PUMP DOES NOT ALARM NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO RUN THE HIGH PRESSURE TEST TWICE, AND THE FIRST TIME DID PASSED, BUT THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT ALARM NO DELIVERY AS IT SHOULD THE SECOND TIME. THE MANUAL PRIME TEST WAS PERFORMED AND THE INSULIN DID EXIT. ADVISED THE CALLER TO CONTINUE USING THE INSULIN PUMP UNTIL THE REPLACEMENT ARRIVES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48748 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization