BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6135220 · Received November 30, 2016

    Report

    Report Number
    2032227-2016-46511
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, MISSING RESERVOIR TUBE O-RING, CRACKED BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS. A TEST RESERVOIR WAS INSTALLED AND DID NOT LOCK IN PLACE DUE TO COMPLETE BROKEN RESERVOIR TUBE LIP NOTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE PLASTIC ON THE RESERVOIR COMPARTMENT BROKE OFF. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787523 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR