BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3022544 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03112
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 06/11/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE TOTAL DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY. A 29 HOURS FLOW ACCURACY TEST WAS PERFORMED AND PUMP WAS DELIVERING WITHIN REQUIRED SPECIFICATIONS. A FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP WAS NOT DETECTING THE CORRECT FORCE. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 32.3 MMOL/L WITHOUT SYMPTOMS AFTER THE PUMP WAS ACCIDENTALLY DROPPED INTO A TOILET. THE PUMP WAS REVIEWED AND THE REPORTER CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT. THE REPORTER CONFIRMED THAT THE PUMP TOTAL DAILY DOSE HISTORY CORRECTLY ADDED UP. CUSTOMER SUPPORT ADVISED THAT THERE WAS NOTHING TO SUGGEST THAT THE EVENTS WERE RELATED TO A MALFUNCTION OF THE DEVICE HOWEVER, THE PUMP WAS BEING RETURNED TO ANIMAS AS A PRECAUTION DUE TO TRAUMA TO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125825 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening