BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3864195 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16411
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/11/2014 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, INFORMATION FOR THE COMPLAINT IS OVERWRITTEN. THE BLACK BOX STARTS ON (B)(6) 2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2014 HAVE BEEN OVERWRITTEN. REVIEW OF THE CURRENT PUMP HISTORY SHOWS NO ALARMS OR WARNINGS RELATED TO THE COMPLAINT. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USER PROGRAMMED BASAL RATE. PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. 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. 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 THE PATIENT HAD A BLOOD GLUCOSE OF (BG) 574MG/DL WITH LARGE KETONES, AND SYMPTOMS OF DEHYDRATION. REPORTER DID NOT HAVE PUMP AT HAND. THIS ISSUE IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP COULD NOT BE ELIMINATED AS A CAUSE OF, OR CONTRIBUTOR TO, THE BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337837 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening