BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4231290 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48476
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED NUMBER RAMPING ANOMALY WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS NOTED ON THE KEYPAD TRACES DURING THE VISUAL INSPECTION. THE INSULIN PUMP WAS MONITORED FOR FOUR DAYS WITH NO LOW BATTERY ANOMALIES NOTED. A BROKEN BATTERY CAP COIN SLOT WAS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, OFF NO POWER TEST, REWIND, AND BASIC OCCLUSION TEST. THE OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT, A STAINED END CAP STICKER AND A STAINED ADDRESS AND SERIAL NUMBER LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE CUSTOMER'S INSULIN PUMP WERE UNRESPONSIVE. HER BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF REPORTING. THE INSULIN PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715971 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR