BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2112858 · Received June 3, 2011

    Report

    Report Number
    2531779-2011-03892
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 400 MG/DL WITH SYMPTOM OF KETONES AFTER THERE WERE MULTIPLE OCCLUSION ISSUES WITH THE ANIMAS PUMP. REPORTEDLY, THE OCCLUSION ALARM HAS OCCURRED 6 TIMES ON (B)(6) 2011 AND 3 TIMES ON (B)(6) 2011. THE PATIENT'S BLOOD GLUCOSE WAS NORMALIZED WITH CORRECTION INSULIN VIA SYRINGE. DURING TROUBLESHOOTING, THE OCCLUSION ISSUE WAS RESOLVED WITH TRAINING. THE ANIMAS REPRESENTATIVE WENT OVER THE CAUSES FOR THE OCCLUSION AND RECOMMENDED THAT THE SITE/CARTRIDE BE CHANGED EVERY 2-3 DAYS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD A HYPERGLYCEMIC EPISODE AFTER THE OCCLUSION ISSUE BEGAN.

    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 10 YR Life Threatening| R