BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4143435 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29963
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND STRIPPED BATTERY CAP COIN SLOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS OF 42 MG/DL. THE CUSTOMER TREATED WITH GLUCOSE TABLETS. THE CUSTOMER REPORTED HAVING DIFFICULTY REMOVING THE BATTERY CAP OF THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A CRACK ON THE HOUSING OF THE INSULIN PUMP. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603290 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR