BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4121094 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-21954
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAILED BATTERY TEST ALARM WAS NOTED. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE OFF NO POWER ALARM FUNCTIONED PROPERLY. THE INSULIN PUMP PASSED THE SELF TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, BROKEN BATTERY TUBE THREADS, AND A STAINED END CAP STICKER. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONICS, MOTOR, VIBRATOR MOTOR OR BATTERY TUBE ASSEMBLY.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARM BUTTON ALARM ERROR, UNRESPONSIVE KEYPAD AND BAD BATTERY TEST. CUSTOMER STATED THAT HE WAS PLAYING TENNIS AND SWEAT GOT INTO IT. CUSTOMER'S BLOOD GLUCOSE WAS 215 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602083 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR