BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3041660 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92403
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST, AND THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE DEVICE HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 130MG/DL. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER EXPERIENCE NAUSEA AND VOMITING. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CALLER STATED THAT SOMETIMES THE DEVICE DOES NOT DELIVER THE INSULIN, AND SHE STRONGLY BELIEVES THAT THE DEVICE IS MALFUNCTIONING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143936 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR