BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5132553 · Received October 7, 2015

    Report

    Report Number
    2032227-2015-53952
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    September 20, 2015
    Report Date
    September 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO INTERFACE BOARD BROKEN SOLDER JOINT. THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIMING, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS WERE UNABLE TO BE PERFORMED DUE TO BLANK DISPLAY ANOMALY. THE DEVICE HAS MINOR SCRATCHES ON THE LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAVE A BLANK SCREEN ON THEIR INSULIN PUMP. CUSTOMER ADVISED THEY WOKE UP WITH LOW BLOOD GLUCOSE IN THE MORNING AND MANUALLY SUSPENDED THE DEVICE WHEN THEY REALIZED THE SCREEN WAS BLANK. TROUBLESHOOTING FOR THE BLANK DISPLAY WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663356 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR