BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3211901 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95473
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 24, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM AND UNRESPONSIVE BUTTONS DUE TO FLATTENED DOME SWITCH ON DOWN ARROW BUTTON. UNIT HAD MOISTURE DAMAGE ON THE KEYPAD TRACES. UNABLE TO PERFORM PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TESTS DUE TO UNRESPONSIVE BUTTON. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNIT HAD SCRATCHED 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS FLUSH. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE HIGH PRESSURE TEST WAS COMPLETED AND PASSED. THE CALLER MENTIONED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THEN THE MOTHER CALLED AND STATED THAT THE INFUSION SET WAS CHANGED THE DAY BEFORE, BUT INSULIN SQUIRTED OUT WHILE HOLDING THE ACTIVATE BUTTON. THE MOTHER STATED THAT THE ALARM HAS BEEN PRESENT FOR SEVERAL MONTHS SINCE HER FATHER PASSED AWAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312103 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization