BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3994119 · Received August 8, 2014

    Report

    Report Number
    2032227-2014-06693
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED ALARMED MOTOR ERROR DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST DUE TO CONSTANT MOTOR ERROR ALARM. INSULIN PUMP RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERRORS ON HIS INSULIN PUMP, DURING REWIND. CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. CUSTOMER STATES INSULIN PUMP PASSED THE SELF TEST. INSULIN PUMP WILL BE REPLACED FOR THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468755 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1