BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2982987 · Received February 28, 2013

    Report

    Report Number
    2531779-2013-02249
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS FOUND TO BE FULLY INTACT AND WAS RESPONSIVE TO BUTTON PRESSES. UNRELATED TO THE COMPLAINT, THE KEYPAD COVER WAS FOUND TO BE FULLY INTACT; NO LIFTING OR DAMAGE WAS NOTED. THE UP AND DOWN ARROW KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE AND REQUIRED EXCESSIVE FORCE TO ELICIT A RESPONSE. THE CONTRAST AND OK KEYPAD BUTTONS WERE FOUND TO BE RESPONSIVE TO BUTTON PRESSES. THE KEYPAD COVER WAS REMOVED; CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS STATING THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND WAS HOSPITALIZED. THE PATIENT REPORTEDLY EXPERIENCED 'SUGAR SHOCK' AND THE DOCTOR DETERMINED THERE WAS A DEFECT IN THE PUMP. THERE WAS REPORTEDLY A DELAY WITH THE BOLUS BUTTON OR NO RESPONSE AT ALL. THE PATIENT STATED THAT THE BOLUS BUTTON REQUIRED MULTIPLE BUTTON PRESSES. THERE WERE NO REPORTED BLOOD GLUCOSE (BG) VALUES AND NO ADDITIONAL DETAILS PROVIDED REGARDING THE "SUGAR SHOCK". THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO THE ALLEGATION THERE WAS A RESPONSE ISSUE WITH THE AUDIO BOLUS BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88248 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R