BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183562 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40332
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING THAT WAS PERFORMED. NO MOTOR ERROR ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. NO MOTOR POSITION ENCODER ALARMS NOTED, UNABLE TO VERIFY ALARM IN THE ALARM HISTORY DUE TO HISTORY FILE WAS OVERWRITTEN. NO MOISTURE DAMAGE WAS NOTED DURING VISUAL INSPECTION. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ACCIDENTALLY DROWNED IN WATER LAST WEEK. CUSTOMER'S MOTHER STATED THERE WAS A CRACKED CASE AND NOW A MOTOR ERROR ALARM OCCURRED DURING BOLUS AND BASAL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 230 MG/DL. CUSTOMER'S MOTHER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER'S MOTHER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER'S MOTHER WAS UNABLE TO CLEAR THE ALARM AND SEE THE ALARM HISTORY. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER'S MOTHER WAS NOT ABLE TO REWIND THE PUMP. CUSTOMER WAS ADVISED TO REMOVE THE PUMP BATTERY TO PREVENT CONTINUED ALARMS. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ASKED TO RETURN THE PUMP FOR ANALYSIS. CUSTOMER'S MOTHER WILL TREAT THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL WITH A SYRINGE ACCORDING TO THE BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664047 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554WWP

    Patients

    Seq Age Sex Outcome Treatment
    1