BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3082863 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05512
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED A "REPLACE CARTRIDGE" ALARM AT 05:28 ON (B)(4) 2012; THIS ALARM WAS CONFIRMED AND DELIVERIES WERE RESUMED AT 07:11 ON (B)(4) 2012. THE LAST BOLUS WAS RECORDED ON (B)(4) 2012 AT 19:51 AND THE LAST BASAL DELIVERY RECORDED WAS (B)(4) 2012 AT 10:37. THERE WERE NO ALARMS RELATED TO THE COMPLAINT RECORDED IN THE BLACK BOX OR ALARM HISTORY. THE USERS PROGRAMMED BASAL RATES ARE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. ON INVESTIGATION, A "REPLACE CARTRIDGE" ALARM WAS REPRODUCED AND DISPLAYED THE CORRECT MESSAGE ON THE DISPLAY SCREEN. THE PUMP WAS EXERCISED FOR 29 HOURS AND WAS FOUND TO BE DELIVERING INSULIN AS INTENDED. ON TESTING, THE DISPLAY SCREEN HAD A PINK CONTRAST. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED APPROPRIATELY WITHOUT DISCOLORATION. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013: THE DISPLAY SCREEN HAD A PINK COLOR CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184464 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR