BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4153756 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35433
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP PASSED THE PRIME TEST, DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY ALARM TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WOKE UP AND HIS BLOOD GLUCOSE WAS 512 MG/DL. HE TREATED WITH A BOLUS DELIVERY AND A MANUAL INJECTION. HE STATED HE FEELS TIRED. CUSTOMER CHANGED HIS INFUSION SET ABOUT THREE HOURS AGO. IN TROUBLESHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WERE AIR BUBBLES IN THE TUBING AND RESERVOIR, BUT THEY WERE PRIMED OUT. INSULIN EXITED DURING THE MANUAL PRIME. THERE WAS NO LEAK. THE SETTINGS AND HISTORY ARE CORRECT. THE DEVICE PASSED THE HIGH PRESSURE TEST. THE CANNULA WAS OCCLUDED. CUSTOMER WAS ADVISED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY INFUSION SET OR SITE ISSUES. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE AND MONITOR HIS BLOOD GLUCOSE. HIS LAST BLOOD GLUCOSE WAS 491 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632179 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention