BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123235 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29476
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE INSULIN PUMP WAS PROGRAMMED WITH CORRECT TIME AND DATE; MONITORED FOR 2 DAYS WITH SEVERAL BOLUSES WERE PROGRAMMED AND DELIVERED. THE INSULIN PUMP WAS DOWNLOADED TO CARELINK AND ALL BOLUS DELIVERED DURING TESTING AND DURING THE TIME UNIT WAS MONITORED WERE PROPERLY RECORDED AND RECORDED AT THE DAILY TOTALS AND BOLUS HISTORY SCREENS. THE CARELINK REPORTS SHOWS ALL BOLUS DELIVERED; NO BOLUS ANOMALY OR BOLUS HISTORY ANOMALY NOTED. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER AND CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD BOLUS ANOMALY. CUSTOMER STATED THERE WAS NO BOLUS HISTORY. ADVISED THE CUSTOMER TO MONITOR BOLUS DELIVERY AND THEN CHECK THE BOLUS HISTORY. CUSTOMER'S MOTHER STATED NOT SURE IF HER SON DID NOT BOLUS OR IF THE INSULIN PUMP WAS NOT RECORDING ALL THE BOLUS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602458 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAP

    Patients

    Seq Age Sex Outcome Treatment
    1