BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142272 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33691
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND MOTOR TEST. NO MOTOR ERROR ALARM OR DISPLACEMENT ANOMALIES WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD RECENTLY BEEN EXPOSED TO STRONG MAGNETIC FIELDS WHEN GOING THROUGH AIRPORT BODY SCANNERS. CUSTOMER REPORTED BEING CONCERNED ABOUT THE INSULIN PUMP BEING ABLE TO FUNCTION PROPERLY. CUSTOMER REPORTED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622064 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR