BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2973129 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-91256
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. THE INSULIN PUMP FUNCTION AND DELIVER BASAL PROPERLY. HOWEVER, THE INSULIN PUMP HAD LOUD MOTOR NOISE DURING REWIND DUE TO FAULTY MOTOR. THE INSULIN PUMP RETURNED WITH BROKEN AND MISSING PART OF RESERVOIR TUBE LIP. CRACKED CASE ABOVE CORNER OF DISPLAY WINDOW AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OVER 300MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THAT THE FOOD INTAKE WAS NOT MATCHING WITH THE BLOOD GLUCOSE. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER WITH CORRECTING THEM. WHILE ASSISTING THE CUSTOMER WITH REWINDING AND PRIMING, THE CUSTOMER GOT A NO DELIVERY ALARM. INSTRUCTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. FURTHER TESTING WAS DECLINED AND THE CUSTOMER REQUESTED HAVING THE DEVICE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75513 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization