BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4200590 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42661
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED ACT BUTTON DOME SWITCH. NO BUTTON ERROR ALARM DURING TESTING. PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER STATED THAT HE HAD BLOOD GLUCOSE READINGS OF 383 MG/DL WHICH IS NOT USUAL FOR HIM, HOWEVER HAS TREATED AND FEELS OK. CUSTOMER'S MOST RECENT BLOOD GLUCOSE READING WAS 73 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678615 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR