BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2080358 · Received May 6, 2011

    Report

    Report Number
    2531779-2011-03201
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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 SHE WOKE UP AND TESTED HER BLOOD GLUCOSE AT 455 MG/DL; SHE REPORTED SIGNS OF THIRST WITHOUT ANY OTHER SYMPTOMS OF HYPERGLYCEMIA OR KETONES. THE PATIENT SAID THAT SHE CORRECTED HER BLOOD GLUCOSE WITH A MANUAL INJECTION AND DID NOT SEEK MEDICAL INTERVENTION. SHE SAID THAT SHE ATTEMPTED TO WAKE UP THE PUMP TO DELIVER A BOLUS AND THE PUMP HAD NO POWER. THE PATIENT REPLACED THE BATTERY TWICE WITHOUT RESTORATION OF POWER. SHE CONFIRMED CORRECT PLACEMENT OF BATTERY IN THE COMPARTMENT, SAID THAT THE BATTERY CAP WAS SECURE AND INTACT, AND NOTED THAT THE CAP WAS ABOUT ONE YEAR OLD. THE PATIENT DENIED ANY DAMAGE TO BATTERY COMPARTMENT AND DENIED ANY KNOWN TRAUMA TO THE PUMP. SHE STATED THAT SHE WEARS THE PUMP INSIDE A LEATHER CASE OR TUCKED INSIDE THE FRONT OF HER BATHING SUIT. THE PATIENT REPORTED THAT SHE SWIMS WITH PUMP ALMOST EVERY DAY AND RECENTLY SWAM IN THE OCEAN. SHE STATED THAT THERE IS NO VISIBLE EVIDENCE OF MOISTURE ANYWHERE ON THE PUMP. THE COMPLAINT IS BEING REPORTED FOR THE ALLEGATION OF POWER LOSS WITHOUT VISIBLE DAMAGE; THE REPORTED BLOOD GLUCOSE DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR