BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3984323 · Received August 6, 2014

    Report

    Report Number
    2032227-2014-05926
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, BASIC OCCLUSION AND PRIME TESTS. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK IN A MOTOR ERROR ALARM DURING BOLUS DELIVERY LOOP. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SON RECEIVED A MOTOR ERROR ON HIS INSULIN PUMP DURING BOLUS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NOT RECORDED. THE MOTOR ERROR OCCURRED SIX TIMES IN THE LAST 30 DAYS. THE INSULIN PUMP WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461373 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1