BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2151844 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04726
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    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 FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 [DATE OF SUBMISSION (B)(6) 2011] - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EVALUATED AND FOUND TO BE DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. UNRELATED TO THE EVENT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING BLOOD GLUCOSE OF 1.7 MMOL/L. THE PATIENT REPORTED THAT SHE TREATED WITH CARBOHYDRATES AND DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT STATED THAT SHE THOUGHT THE PUMP WAS DELIVERING EXCESS INSULIN. DURING A REVIEW OF THE PUMP TOTAL DAILY DELIVERY HISTORY, THE PATIENT REPORTED THAT THE DELIVERY AMOUNTS DID NOT ADD UP CORRECTLY FOR BOLUSES. THE PATIENT REPORTED THAT WHEN SHE WENT BACK TO THE TOTAL DAILY DELIVERY HISTORY THERE WERE MISSING ENTRIES THAT WERE PREVIOUSLY IN THE HISTORY. THE PATIENT CONFIRMED THAT THE PUMP WAS SUGGESTING THE CORRECT AMOUNTS FOR BOLUSES AND THE TOTAL DELIVERY FOR BASAL WAS CORRECT. THE PATIENT HAS NOT HAD ANY CHANGES IN DIET BUT HAS RECENTLY DISCONTINUED BIRTH CONTROL MEDICATION. THE PATIENT ALSO REPORTED THAT THE PUMP WAS RECENTLY EXPOSED TO X-RAY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention