BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2002550 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00881
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT FAILED TO PROGRAM THE PUMP THAT WAS SHIPPED TO HER AS A REPLACEMENT FOR A DAMAGED PUMP THAT WAS UNDER WARRANTY. THE PUMP ARRIVED WITH LITERATURE THAT INSTRUCTS THE USER TO PROGRAM THE PUMP WITH THE USER'S CURRENT SETTINGS. IN ADDITION TO THE INSTRUCTIONS SENT TO THE PATIENT, THE PUMP EMITS AN ALARM THAT WARNS THE PATIENT THAT THE BASAL RATE PROGRAM IS EMPTY. THE PATIENT MUST MANUALLY CONFIRM THE ALARM TO CLEAR IT. THE ALARM IS DISPLAYED EACH TIME THE PATIENT WAKES UP THE PUMP. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BLOOD GLUCOSE 200MG/DL TO 400MG/DL WITH SHORTNESS OF BREATH AND DIZZINESS SINCE YESTERDAY; SHE DENIED PRESENCE OF KETONES. SHE STATED THAT SHE RECEIVED A REPLACEMENT PUMP AND BEGAN TO USE IT YESTERDAY. THE PATIENT SAID THAT SHE RECEIVED A MESSAGE ON THE PUMP THAT NOTIFIED HER THAT THE BASAL PROGRAM WAS EMPTY; SHE SAID THAT SHE DID NOT KNOW HOW TO PROGRAM THE BASAL RATE SETTINGS AND THOUGHT THAT THE PUMP WAS ALREADY PROGRAMMED. THE PATIENT NOTED THAT SHE PROGRAMMED THE TIME AND DATE ON THE VERIFICATION SCREEN, BUT DID NOT PROGRAM ANYTHING ELSE. THE PATIENT REPORTED THAT HER BASAL RATE IS ONE UNIT PER HOUR FOR 24 HOURS. THE PATIENT WAS INSTRUCTED TO CONFIRM THE MESSAGE THAT THE BASAL PROGRAM IS EMPTY AND WAS ASSISTED IN PROGRAMMING THE PUMP PER USUAL CUSTOMER SUPPORT PROTOCOL. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR