BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3980865 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89843
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE OFF NO POWER ALARM FUNCTIONED PROPERLY AND PASSED THE SELF TEST. NO UNEXPECTED BATTERY OUT LIMIT ALARM OR UNEXPECTED NUMBER RAMPING ANOMALY WAS NOTED. THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AND ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS.

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED FOR BUTTON ERROR. THE REPORTER WAS UNABLE TO CLEAR THE ALARM. BLOOD GLUCOSE READING AT THE TIME WAS 360 MG/DL. DURING THE PHONE CALL THE REPORTER ALSO HAD AN ALARM FOR BATTERY OUT LIMIT. THE REPORTED STATED THAT HIS DAUGHTER HAD A SEIZURE AND HE IS UNCERTAIN IF THE INSULIN PUMP HAD CAUSED IT. THE DAUGHTER HAD LOW BLOOD GLUCOSE AT THE TIME OF THE SEIZURE. THE REPORTER HAS TREATED HIS DAUGHTER WITH MANUAL INJECTION. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456450 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAL

    Patients

    Seq Age Sex Outcome Treatment
    1