BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4122886 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-28759
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO FLATTENED EXPRESS BOLUS, ESC, ACT, UP AND DOWN BUTTON DOME SWITCH. ALSO RECEIVED WITH SCRATCHED LCD WINDOW. THIS MDR RELATED TO THE (B)(4)MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 134 MG/DL. CUSTOMER STATED THAT THE DOCTOR RECOMMENDED SHE CALL MEDTRONIC TO GET A REPLACEMENT PUMP. CUSTOMER'S NURSE PRACTIONER ALSO NOTICED IT WAS A PROBLEM. CUSTOMER ALSO STATED THAT SHE HAS TO PUT A LOT OF PRESSURE ON THE KEYPAD IN ORDER TO MAKE IT WORK. CUSTOMER REPORTED THAT THE ARROW BUTTONS USED TO HAVE AN ISSUE, BUT THE BUTTONS ARE NOW OKAY. CUSTOMER STATED THAT THE BUTTONS WERE ALWAYS LIKE THAT. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601156 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR