BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3011711 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-91969
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. MFG. REPORT 1 OF 2, MEDWATCH REPORT # 3004209178-2013-91969. MFG. REPORT 2 OF 2, MEDWATCH REPORT # 3004209178-2013-91970 .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING AN URGENT CARE VISIT DUE TO HIGH BLOOD GLUCOSE OF 311MG/DL. THE CALLER MENTIONED THAT HE WAS GETTING NO DELIVERY ALARMS AND SKIN IRRITATION EVEN AFTER USING DIFFERENT CANNULAS. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND MULTIPLE NO DELIVERY ALARMS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO REMOVE THE CANNULA AND IT WAS BENT AT THE PART THAT CONNECTS TO THE TUBING, BUT IT WAS NOT OCCLUDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114211 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 54 YR Hospitalization