BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3850077 · Received June 4, 2014

    Report

    Report Number
    2531779-2014-15784
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 08/07/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THAT ON SEVERAL OCCASIONS THE PATIENT ENTERED CARBOHYDRATE GRAMS INTO METER AND BOLUS RECOMMENDATION VARIES DESPITE HAVING A CONSTANT I:C RATIO AND IS CONFIDENT THAT THIS IS UNRELATED TO INSULIN ON BOARD (IOB) AND BLOOD GLUCOSE (BG) VALUE. THE REPORTER STATED THAT THEY ENTERED CARBOHYDRATES FOR DINNER AND LATER ENTERED ADDITIONAL CARBS FOR DESSERT AND PUMP WILL RECOMMEND NO INSULIN DESPITE BG BEING IN TARGET RANGE. THE PATIENT LOST FAITH IN THE METER AND INSISTING ON REPLACEMENT. THIS REPORT IS BEING MADE DUE TO HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325748 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR