BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2921200 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00831
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. A NORMAL 10 U BOLUS AND A 10 U AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. TYPICAL USAGE ALARMS WERE OBSERVED IN THE ALARM HISTORY. THE TDD'S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. THE PUMP COMPLETED AND PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. UNRELATED TO THIS COMPLAINT, THE DISPLAY SCREEN HAS A PINKISH CONTRAST. REMOVED PUMP COVER AND REPLACED PINK SCREEN WITH NEW TEST SCREEN. TEST SCREEN HAS NORMAL CONTRAST AND NO SIGN OF DISCOLORATION OR FADING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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

    ON (B)(6) 2012, ANIMAS RECEIVED A MESSAGE FROM THE PATIENT STATING SHE EXPERIENCED A RECENT "DIABETIC KETOACIDOSIS (DKA) EPISODE AND THAT THERE MAY HAVE BEEN AN ISSUE WITH THE PUMP. IT WAS NOTED THAT THE PATIENT IS CURRENTLY NOT USING THE PUMP. THERE WAS NO ADDITIONAL INFORMATION FOR THIS COMPLAINT. CUSTOMER SUPPORT (CS) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT AND HAS BEEN UNSUCCESSFUL. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED A DKA EPISODE AND DO THE ALLEGATION OF A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26212 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening