BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4202024 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-24014
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    April 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE AND FLUSH DRIVE SUPPORT DISK. THE MOTOR WAS RECEIVED WITH A CORRODED HOME SWITCH. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MOTOR ERROR ON HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE ALARM WAS CLEARED. CUSTOMER USES THE SENSOR FEATURE. CUSTOMER WAS ADVISED THAT A FALSE MOTOR ERROR MAY BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH DURING BOLUS. WHEN CUSTOMER TRIED TO REWIND THE DEVICE, IT ALARMED. THE DEVICE WAS NOT BUMPED OR DROPPED. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577182 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR