BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 2140290 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04465
    Event Type
    Injury
    Date Received
    June 27, 2011
    Report Date
    May 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: INSULIN INFUSION PUMP BATTERY CAP. A DAMAGED BATTERY CAP IS GENERALLY DETECTABLE AND OBVIOUS TO THE USER; THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER BLOOD GLUCOSE (BG) WAS "HIGH" ONE MORNING AFTER THE PUMP HAD BEEN REBOOTING; NO BG VALUES WERE GIVEN. SHE NOTED THAT SHE HAS NEVER CHANGED THE BATTERY CAP, AND THAT THE O-RING WAS VISIBLE. THE PATIENT STATED THAT THE BATTERY CAP KEEPS TURNING WHILE ATTEMPTING TO TIGHTEN THE CAP. SHE STATED THERE WERE NO CRACKS OR DENTS IN THE BODY OF THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED A HIGH BG WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR