BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3800318 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-12973
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN 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 PATIENT CONTACTED ANIMAS ALLEGING THAT HER BLOOD GLUCOSE (BG) EARLIER THAT DAY HAD BEEN AROUND 400MG/DL WITH UNSPECIFIED KETONES. THE PATIENT NOTED THAT AT THE TIME OF THE CALL TO ANIMAS, HER BG WAS AROUND 200MG/DL. NO OTHER INFORMATION WAS PROVIDED. CUSTOMER TECHNICAL SUPPORT MADE ATTEMPTS TO FOLLOW-UP WITH THE PATIENT FOR TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY, AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR AT THE TIME OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277968 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening