BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3013345 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02864
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/22/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX DATA STARTED ON (B)(6) 2013 DUE TO CONTINUED USE OF THE PUMP. THE BLACK BOX DATA AND HISTORIES FOR THE EVENT WERE OVERWRITTEN. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE BATTERY CAP/CARTRIDGE CAP WAS NOT RETURNED; THEREFORE, TEST CAPS WERE USED TO COMPLETE TESTING. THE PUMP PASSED THE DELIVERY ACCURACY TEST AND WAS DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAD A PINK CONTRAST. THE BATTERY COMPARTMENT WAS ALSO CRACKED BELOW THE BUMPER PAD. 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. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 44MG/DL. THE REPORTER BELIEVES THAT THE BASAL RATES ARE TOO HIGH IN THE EVENING. THE REPORTER WANTED TO ADJUST THE BASAL RATES FOR THIS. ADDITIONALLY THE PUMP TIME WAS SET INCORRECTLY, AS IT WAS NOT ADJUSTED FOR DAYLIGHT SAVINGS TIME. THE REPORTER INDICATED THAT THEY ARE NOT GOING TO CORRECT THE PUMP TIME AT THIS TIME AND WILL WAIT UNTIL THE TIME CHANGES BACK. THE REPORTER BELIEVES THAT THE BASAL RATES ARE SET TOO HIGH. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS RELATED TO USE ERROR AND BASAL RATES THAT WERE TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115141 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening