BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972292 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88717
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBER RAMPING ANOMALY WAS NOTED ON THE DISPLAY. THE INSULIN PUMP DID NOT UNEXPECTEDLY ACCESS THE BOLUS MENU SCREEN DURING THE TESTING. THE FUNCTIONAL TEST COULD NOT BE PERFORMED, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS, DUE TO THE UNRESPONSIVE BUTTONS. NO MISSING ADDRESS AND SERIAL NUMBER LABEL WAS NOTED. THE SERIAL NUMBER LISTED ON SAP MATCHES THE SERIAL NUMBER LISTED ON THE LABEL AND ON THE INSULIN PUMP STATUS SCREEN. NO LABEL ANOMALY WAS NOTED. THE INSULIN PUMP HAD A MISSING KEYPAD OVERLAY, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP, AND MOISTURE DAMAGE TO THE ELECTRONIC ASSEMBLY AND MOTOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HOSPITALIZATION DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE READINGS OF OVER 500 MG/DL. CUSTOMER WAS TREATED WITH INSULIN THROUGH THE IV AT THE HOSPITAL. CUSTOMER WAS UNABLE TO WALK AND WAS NOT FEELING WELL PRIOR TO THE HOSPITALIZATION. CUSTOMER REPORTED THEY SUFFER FROM NEPHRITIC SYNDROME AND HAVE BEEN ON MEDICINE THAT MAY HAVE CAUSED THE ELEVATED BLOOD GLUCOSE READINGS. CUSTOMER REPORTED THAT THE BUTTONS ON THE INSULIN PUMP ARE STICKING AND THAT THE SCREEN WAS FLIPPING BACK AND FORTH. CUSTOMER FURTHER REPORTED THAT THE DISPLAY AUTOMATICALLY WENT TO BOLUS ON ITS' OWN. CUSTOMER MENTIONED JUMPING IN THE POOL WITH THE INSULIN PUMP AND RECEIVING A BUTTON ERROR ALARM SEVERAL MONTHS AGO. CUSTOMER'S RECENT BLOOD GLUCOSE READINGS ARE 148 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447317 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization