BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2981729 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-91414
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 HAVING LOW BLOOD GLUCOSE OF 28MG/DL AND THE PARAMEDICS WERE CALLED. THEY TREATED HIS BLOOD GLUCOSE WITH AN INJECTION TO INCREASE HIS BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT HIS BLOOD GLUCOSE HAS BEEN LOW FOR A FEW DAYS. THE CUSTOMER MENTIONED THAT THE DRIVE SUPPORT CAP WAS FLUSH. ASSISTED THE CALLER TO RUN THE DISPLACEMENT AND SELF TEST AND THEY PASSED. THE CALLER WAS CONCERNED THAT THE BOLUS WIZARD WAS GIVING HIM TOO MUCH INSULIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84250 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR