BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6170723 · Received December 13, 2016

    Report

    Report Number
    2032227-2016-49485
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    March 16, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP HAD A BLANK DISPLAY SCREEN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS INFORMED THAT (B)(6) AAA ALKALINE BATTERIES ARE MOST EFFECTIVE. THE CUSTOMER WAS ASSISTED WITH THE ISSUE BUT THE BLANK DISPLAY WAS NOT RESOLVED. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A REPLACEMENT INSULIN PUMP WAS SHIPPED TO THE CUSTOMER. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820143 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR