BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4200199 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42674
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH UNRESPONSIVE BUTTONS, DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. INSULIN PUMP ALSO RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED CASE ON RESERVOIR TUBE WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS A BUTTON ERROR ALARM. THE BLOOD GLUCOSE READING IS UNKNOWN. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680197 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR