BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3760388 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10569
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS:.1) ONE OCCLUSION OBSERVED IN PUMP HISTORY AT 3:56AM ON (B)(6) 2014; FORCE AT TIME OF OCCLUSION IS HIGH. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. FORCE SENSOR CALIBRATION TEST REVEALED SENSOR IS DETECTING LOW FORCE AT 5LBS. PUMP EXERCISED FOR 24 HOURS WITH NO OCCLUSIONS OCCURRING. AN OCCLUSION WAS INDUCED AND PUMP GIVES APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED" ALARM. THE RESISTANCE ON THE FORCE SENSOR MEASURED AND FOUND WITHIN SPECIFICATIONS; 6.6K. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR SHIM. 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 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE PUMP DID NOT EMIT AN OCCLUSION ALARM. THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 32MMOL/L WITH SYMPTOMS OF DEHYDRATION, NAUSEA, VOMITING AND MODERATE KETONES. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES MANAGEMENT CARE. THIS REPORT IS BEING MADE DUE TO THE HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED DUE TO AN ALLEGED ABSENCE OF OCCLUSION ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240863 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening