BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2902259 · Received January 8, 2013

    Report

    Report Number
    2032227-2013-00066
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 800 MG/DL. IT WAS STATED THAT THE CUSTOMER ALSO HAD A COLD. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED WITH THE WRONG TIME AND DATE. ASSISTED WITH THE CORRECT PROGRAMMING. ALL OTHER SETTINGS WERE CORRECT. FOUND NO DELIVERY ALARMS IN THE ALARM HISTORY. THE CALLER STATED THAT THERE WAS SOME BOLUSES MISSING FROM THE BOLUS HISTORY. HAD THE CALLER PROGRAM A SMALL BOLUS, AND IT DID APPEAR IN THE BOLUS HISTORY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. A TUBING CLAMP WAS SHIPPED TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9733 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization