BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3971921 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88580
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. UNIT RECEIVED WITH INTERMITTENT ACT BUTTON DUE TO FLATTENED DOME SWITCH. (CREASED) NO BUTTON ERROR ALARMS NOTED. UNIT RECEIVED WITH SCRATCHED LCD WINDOW. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT BOLUS DOES NOT WORK, AND THEY HAVE TO CONSTANTLY PUSH THE BOLUS BUTTON. THE BLOOD GLUCOSE READING IS 134 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446438 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR