BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3121150 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93762
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH AN ALARM DURING THE BASIC OCCLUSION TEST AS A RESULT OF A MISSING MOTOR SUPPORT DISK. THE DEVICE HAD A CRACKED DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 540MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT DEVICE ALARMED. THE CALLER STATED THAT THE DRIVE SUPPORT CAP APPEARS TO BE SLIGHTLY INDENTED. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221752 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 44 YR