BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183180 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40074
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. 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. (B)(4)

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. THE LOW RESERVOIR ALARM FUNCTIONED PROPERLY. NO BUTTON ERROR ALARM WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS NOTED ON THE KEYPAD TRACES. SEVERAL BOLUSES WERE PROGRAMMED AND DELIVERED PROPERLY. BOLUSES RECORDED PROPERLY IN THE BOLUS HISTORY. DAILY TOTALS FUNCTIONED PROPERLY. THE INSULIN PUMP WAS MONITORED AND NO UNEXPECTED BOLUSES WERE NOTED. THE BOLUS WIZARD FUNCTIONED PROPERLY. NO UNEXPECTED INSULIN SENSITIVITY CHANGE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS IN THE RANGE OF 45 MG/DL TO 55 MG/DL. THE CUSTOMER AND DOCTOR OF THE CUSTOMER BOTH ARE OF THE OPINION THAT THE INSULIN PUMP WAS OVER DELIVERING INSULIN TO THE CUSTOMER. THE CUSTOMER REPORTED THAT HE HAS BEEN GETTING LOW BLOOD GLUCOSE LEVELS LATELY. TROUBLESHOOTING WAS DONE. THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED DUE TO A NON-DIABETES RELATED EVENT BUT HAD TO BE TREATED WITH GLUCAGON FOR HAVING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER WOULD LIKE TO HAVE THE INSULIN PUMP REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660302 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR