BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3034032 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-92316
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

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

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH MOTOR ERROR ALARM AND PRIME ALARM DURING BASIC OCCLUSION TEST DUE TO LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP RECEIVED WITH A CRACKED CASE DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING ISSUES WITH PRIME/REWIND, AND THE INSULIN PUMP ALARMED. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 54MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT WAS PROTRUDED. THE CUSTOMER STATED THAT THE DEVICE ALSO ALARMED MOTOR ERROR. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137124 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 35 YR