BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3791302 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84228
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING THE BOLUS/BASAL 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.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE PRIMING, AND THE DEVICE WAS RESETTING BY IT SELF. THE BLOOD GLUCOSE READING WAS 124MG/DL. THE CALLER MENTIONED THAT THE DEVICE WAS EXPOSED TO AN X-RAY MACHINE AT THE AIRPORT. TROUBLESHOOTING WAS PERFORMED, AND THE DISPLACEMENT TEST FAILED AS WELL THE DEVICE WAS STUCK IN THE PRIME LOOP. REVIEWED THE ALARM HISTORY AND FOUND NO RESERVOIR, SEVERAL MOTOR ERRORS, CHECKING SETTINGS AND OTHER TWO ALARMS. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267482 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR