BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3933380 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-20002
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. IF THE PRODUCT IS RETURNED, AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED HYPERGLYCEMIA WHILE ON THE PUMP DUE TO AN ISSUE WITH INTERMITTENT POWER. THE REPORTER STATED THAT THE PATIENT HAD EXPERIENCED A BLOOD GLUCOSE LEVEL OF 360 MG/DL AND HAD LARGE KETONES. THE PATIENT REPORTEDLY HAD DISCONTINUED PUMP THERAPY AT THE TIME OF THE CALL. IT IS UNKNOWN WHEN THE ISSUE BEGAN, OR WHEN THE PATIENT HAD ALLEGEDLY EXPERIENCED THE HYPERGLYCEMIC EVENT. THE REPORTER REVIEWED THE PUMP WITH A CUSTOMER TECHNICAL SUPPORT REPRESENTATIVE WHERE IT WAS REVEALED THAT THE BATTERY CAP WAS DAMAGED. THE REPORTER STATES THAT THE THREADS OF THE BATTERY CAP WERE STRIPPED AND THAT THERE WAS SOME DAMAGE TO THE CONTACT ON THE CAP. THE REPORTER ALSO REVEALED THAT THE BATTERY CAP HADN¿T BEEN REPLACED ON THE PUMP FOR SEVEN TO TWELVE MONTHS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON PUMP THERAPY RELATING TO THE BATTERY CAP BEING DAMAGED AFTER PROLONGED USE, CAUSING AN INTERMITTENT POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409192 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening