BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221416 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46693
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE OF 519 MG/DL AND WAS NOT SURE WHY. CUSTOMER'S BLOOD GLUCOSE DID LOWER TO 140 MG/DL. CUSTOMER TREATED HIGH WITH THE INSULIN PUMP ONLY. CUSTOMER SYMPTOMS WERE DRY MOUTH, AND CHECKED FOR KETONES. THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. CUSTOMER DISCONNECTED FROM QUICK RELEASE. NO AIR, LEAKS, OR DAMAGE NOTED. MANUAL PRIME WAS PERFORMED, INSULIN DID EXIT. SETTING ON THE DEVICE WERE CORRECT ON A LOW RESERVOIR ALARM WAS NOTED ON THE DEVICE. CUSTOMER DID NOT HAVE A TUBING CLAMP TO PERFORM HIGH PRESSURE TEST. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701621 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR