BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3233299 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-95804
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 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

    THE CUSTOMER REPORTED THAT SHE IS HAVING LOW AND HIGH BLOOD GLUCOSE. THE CALLER STATED THAT SHE WAS UNRESPONSIVE, AND HER BOYFRIEND CALLED THE PARAMEDICS. THE CALLER STATED THAT SHE TOOK 2 UNITS OF INSULIN TO DROP HER BLOOD GLUCOSE TO 85MG/DL WHEN IT USUALLY TAKES SOMEWHERE AROUND 6.0 UNITS. THE CALLER STATED THAT WHEN THE PARAMEDICS ARRIVED HER GLUCOSE LEVEL WAS 32MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE CUSTOMER MENTIONED THAT SHE REMOVED THE CANNULA AND IT WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334660 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention