BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4232992 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48595
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    November 3, 2014
    Report Date
    April 13, 2015
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO BATTERY IN THE BATTERY TUBE. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS INCLUDING THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. A CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS WERE NOTED DURING THE VISUAL INSPECTION. DATA ANALYSIS COULD NOT BE PERFORMED AS THE INSULIN PUMP WAS RECEIVED WITHOUT THE BATTERY IN THE BATTERY TUBE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    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. 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

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. NO FURTHER DETAILS, INCLUDING THE DATE OF HER PASSING, WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715293 530G INSULIN PUMP OZO OZO MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death