BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2970489 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91152
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CURRENTS WITHIN SPECIFICATIONS. THE DEVICE ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. UNABLE TO CONFIRM MOTOR ERROR ALARMS. THE MOTOR PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING WAS 98MG/DL. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT TEST AND PASSED. THE CUSTOMER ALSO MENTIONED THAT THE DEVICE HAD A BLANK DISPLAY MULTIPLE TIMES. ADVISED THE CALLER 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
    74275 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 30 YR