BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3894875 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03367
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, SELF TEST AND ERROR TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. NO PRIME ALARM NOTED. INSULIN PUMP WAS UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME AND FILL ANOMALY. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP.

    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. PLEASE SEE MEDWATCH REPORT # 3004209178-2014-86213.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. SHE WAS UNABLE TO RETRIEVE HER INSULIN PUMP SETTINGS AND WAS UNABLE TO CONTINUE TROUBLESHOOTING DUE TO A LOOP IN THE ALARM. ON (B)(6) 2014, IT WAS REPORTED THAT THE CUSTOMER WENT INTO A COMA AFTER HAVING SURGERY, BUT SHE STATED THAT SHE HAD NOT BEEN WEARING HER INSULIN PUMP AT THE TIME OF THE INCIDENT; THE EVENT WAS NOT RELATED TO HIGH OR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVELS DUE TO BEING OFF THE INSULIN PUMP FOR 3 DAYS AND CALLED FOR ASSISTANCE WITH DEVICE SETUP BECAUSE SHE COULD NOT REMEMBER HOW TO PROGRAM THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370361 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization