BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4213258 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37265
    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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED BUTTON ERROR ALARMS WERE NOTED. ALL BUTTONS FUNCTIONED PROPERLY. HOWEVER CORRODED KEYPAD TRACES WERE NOTED DURING VISUAL INSPECTION. THE PUMP HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED CASE AT THE LCD WINDOW CORNERS, A CRACKED LCD WINDOW, A CRACKED RESERVOIR TUBE LIP AND SCRATCHES ON THE RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM WHILE ATTEMPTING A QUICK BOLUS. HE STATED HIS BUTTONS WAS STUCK, LEADING TO THE BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 194 MG/DL. 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
    648675 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR