BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3980859 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89841
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO A FAULTY FORCE SENSOR. UNABLE TO CONFIRM THE MOTOR ERROR ALARM DUE TO THE PRIME ANOMALY. THE MOTOR PASSED THE MOTOR TEST. THE DEVICE HAD MINOR SCRATCHES ON THE LCD DISPLAY WINDOW AND CRACKS ON THE BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED FOR MOTOR ERROR. THE REPORTER MENTIONED THAT THIS ALARM HAS OCCURRED 4 TIMES IN THE LAST 8 MONTH PERIOD. BLOOD GLUCOSE READING AT THE TIME WAS 91 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456448 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWB

    Patients

    Seq Age Sex Outcome Treatment
    1