BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123662 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29815
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONING PROPERLY. NO UNLOCKED J2 LCD KEYPAD CONNECTOR DURING VISUAL INSPECTION. NO COSMETIC DAMAGE NOTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS TRYING TO FILL HER RESERVOIR AND THE BUTTONS WERE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602323 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR