BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3930449 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19799
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS:. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. THE TDD¿S IN PUMP HISTORY ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. NO ALARMS RELATED TO THE COMPLAINT IN ALARM HISTORY. PUMP FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAS A PINKISH CONTRAST AND THE PUMP HAS NO VIBRATION. REMOVED THE PUMP COVER; THE VIBRATE MOTOR PINS ARE NOT MAKING A CONNECTION WITH THE PRINTED CIRCUIT BOARD. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 500 MG/DL WITH EXTREME THIRST AND HAD TAKEN 30U BY SYRINGE. TROUBLESHOOTING WITH CUSTOMER SUPPORT (CS) FOUND THAT THE BASAL HISTORY DOES NOT MATCH ACTIVE BASAL PROGRAM. CS ADVISED PATIENT TO DISCONTINUE USE OF THIS PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE DISCREPANCY IN BASAL HISTORY WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408118 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening