BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974093 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05256
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TEST. NO EXCESSIVE NO DELIVERY ALARMS OR MOTOR ERROR ALARM NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE UNIT FUNCTIONED PROPERLY. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 450 MG/DL. CUSTOMER THOUGHT SHE HAD A STOMACH VIRUS AND WAS UNAWARE THAT SHE WAS IN DIABETIC KETOACIDOSIS. CUSTOMER STATED CANNULA WAS BENT; HOME GLUCOMETER WAS READING 250 MG/DL, GLUCOSE MONITORING SYSTEM WAS INACCURATE, AND THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER'S FATHER TOOK HER TO THE EMERGENCY ROOM. SHE THEN STARTED THROWING UP AND WAS UNAWARE OF WHAT WAS GOING ON. SHE WAS ADMITTED FOR A WEEK, ON INSULIN DRIP FOR FOUR DAYS THEN WAS PUT ON THE DEVICE. CUSTOMER HAD CHANGED COMPLETE SET AND WAS UNABLE TO TROUBLESHOOT FOR NO DELIVERY. TROUBLESHOOTING FOR MOTOR ERROR PERFORMED. BLOOD GLUCOSE WAS 136 MG/DL. ALARM OCCURRED DURING BOLUS. NO SIGNIFICANT EVENT OR ENCOUNTER WITH MRI. CUSTOMER DOES NOT USE SENSOR FEATURE. SHE WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451013 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization