BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4232015 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48451
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 23, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: NO BUTTON ERROR ALARM NOTED. ACT BUTTON DID NOT RESPOND DUE TO CORRODED KEYPAD TRACE. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR THAT COULD NO BE CLEARED. HER BLOOD GLUCOSE WAS 57MG/DL AT THE TIME OF REPORTING. SHE ALSO STATED THAT THE BOTTOM OF THE SCREEN APPEARED TO HAVE A SLIGHT CRACK. THE INSULIN PUMP WAS RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715770 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR