BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6111462 · Received November 17, 2016

    Report

    Report Number
    2032227-2016-42793
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    November 12, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD UNRESPONSIVE ESCAPE BUTTON DUE TO MOISTURE DAMAGE KEYPAD TRACES. UNABLE TO PERFORM OPERATING CURRENTS, SELF-TEST, UNEXPECTED RESTART ERROR TEST, REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST OR VERIFY FAILED BATTERY TEST ALARM DUE TO UNRESPONSIVE BUTTON. NO MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY DURING OUR VISUAL INSPECTION. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND SCRATCHED RESERVOIR TUBE WINDOW.

    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. DURING TROUBLESHOOTING THE CUSTOMER MENTIONED THAT THE FAILED BATTERY TEST ALARM OCCURRED WITH EVERY NEW BATTERY. THE PATIENT ALSO MENTIONED THAT THE INSULIN PUMP ALARMED BUTTON ERROR RIGHT AFTER RECEIVING A FAILED BATTERY TEST ALARM. THE PATIENT'S LAST RECORDED BLOOD GLUCOSE VALUE WAS 94 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO WATER PRIOR TO THE BUTTON ERROR ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762407 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR