BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3981995 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05430
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. THE DEVICE PASSED THE SELF TEST, ERROR TEST AND DISPLACEMENT TEST. HOWEVER, THE UNIT ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO A FORCE SENSOR DAMAGED BY MOISTURE. THE MOTOR WAS FOUND WITH CORROSION DURING A VISUAL INSPECTION. UNABLE TO TEST THE MOTOR DUE TO THE MOTOR ANOMALY. THE UNIT WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. UNABLE TO PERFORM OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARMS. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, DISPLAY WINDOW, RESERVOIR TUBE AND LIP, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHED LCD WINDOW.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S MOTHER CALLED STATING CUSTOMER WAS HOSPITALIZED FOR FOUR HOURS DUE TO BLOOD GLUCOSE 30 MG/DL. SHE STATED THAT CUSTOMER'S BLOOD GLUCOSE WAS FLUCTUATING AND SHE WAS DEHYDRATED. NO TROUBLESHOOTING WAS DONE AS CUSTOMER DID NOT HAVE HER INSULIN PUMP WHILE AT THE HOSPITAL. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458486 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization