BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221361 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31208
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED TO BE RETURNED TO ANIMAS. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2014, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 605 MG/DL WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. REPORTEDLY, THE PATIENT WAS TREATED IN THE EMERGENCY ROOM BY THEIR HEALTHCARE PROVIDER AND RECEIVED INSULIN VIA INJECTION AND INSULIN VIA THEIR PUMP. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS DETERMINED THAT THE PATIENT FAILED TO COMPLETELY PRIME THE TUBING. THERE WERE NO PUMP DEFECTS FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA RELATED TO USE ERROR IN NOT COMPLETELY PRIMING THE TUBING PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701345 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R