BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4100798 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23756
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. NO UNEXPECTED BATTERY ALARMS NOTED. THE INSULIN PUMP PASSED BASIC OCCLUSION TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS WERE NOTED HOWEVER, UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RELAY. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER STATED THAT SOMETHING WAS WRONG WITH THE INSULIN PUMP SO THEY CHANGED THE BATTERY, FILLED UP THE DEVICE AND THE DEVICE ALARMED BATTERY ERROR. THE CUSTOMERS BLOOD GLUCOSE HAD BEEN ABOVE 500 MG/DL FOR TWO DAYS, AND THEY WERE FEELING REALLY BAD. AT THE TIME OF THE PHONE CALL, THE CUSTOMER'S BLOOD GLUCOSE WAS 520 MG/DL. THE CUSTOMER DOES USE THE SENSOR FEATURE. THEY WERE ABLE TO REWIND THE DEVICE. IN THE ALARM HISTORY THERE WERE NO DELIVERY, MOTOR ERROR, AND LOW RESERVOIR ALARMS PRESENT. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. THE CUSTOMER DECLINED TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572062 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR