BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4213251 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37264
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH ALL BUTTONS RESPONDING PROPERLY. NO BUTTON ERROR ALARMS NOTED. HOWEVER, SLIGHTLY MOISTURE DAMAGE FOUND AT KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHED LCD WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 290 MG/DL. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS, LEADING TO THE ALARM. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADD'L INFO IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648704 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR