BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4111188 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-22985
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH A64 DUE TO FAULTY Y1/RFB. NO COSMETIC DAMAGE NOTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP'S NUMBERS WERE COUNTING DOWN. BLOOD GLUCOSE LEVEL WAS 190 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589689 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR