BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4181076 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-20022
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 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. 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. 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 THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. THE INSULIN PUMP WAS RECEIVED STUCK ON A MOTOR ERROR ALARM DURING THE BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. NO MOTOR ENCODER POSITION ERROR ALARM COULD BE CONFIRMED DUE TO AN OVERWRITTEN HISTORY FILE. THE INSULIN PUMP PASSED THE RESET ERROR TEST AND NO SETTING ERASURE WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED A MOTOR ERROR ALARM WHILE PRIMING. THE CUSTOMER STATED THE INSULIN PUMP WAS NOT DROPPED OR BUMPED. THE CUSTOMER'S SETTINGS ON THE INSULIN PUMP WAS ALSO DELETED. CUSTOMER'S BLOOD GLUCOSE WAS 16 MMOL/L. CUSTOMER WAS ADVISED TO REPLACE THEIR INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661318 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCMH

    Patients

    Seq Age Sex Outcome Treatment
    1