BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2933845 · Received January 29, 2013

    Report

    Report Number
    2032227-2013-00380
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    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 ON (B)(6) 2013 DUE TO EARLY LABOR SYMPTOMS, NOT DUE TO ELEVATED BLOOD GLUCOSE LEVELS. IT WAS STATED THAT THE CUSTOMER WAS GIVEN STEROIDS, AND THE NEXT DAY SHE BEGAN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS THEN HOSPITALIZED ON (B)(6) 2013 WITH DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. ASSISTED THE CALLER IN PROGRAMMING THE FIXED PRIME. THE CUSTOMER LATER CALLED TO REPORT THAT SHE HAD ALSO BEEN TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2013 DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS GREATER THAN 200 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING, AND REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39707 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization