BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6659610 · Received June 22, 2017

    Report

    Report Number
    2531779-2017-13128
    Event Type
    Injury
    Date Received
    June 22, 2017
    Report Date
    May 31, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 2017 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON AN UNSPECIFIED DATE, THE PATIENT WAS HOSPITALIZED DUE TO BLOOD GLUCOSE (BG). NO G VALUES OR SIGNS OR SYMPTOMS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF INITIAL CONTACT. CUSTOMER TECHNICAL SUPPORT MADE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THE REPORTER FOLLOWED UP ON (B)(6) 2017 AND STATED SHE DID NOT WISH TO TROUBLESHOOT AT THAT TIME AND WOULD CALL BACK. ON (B)(6) 2017 THE REPORTER FOLLOW-UP AGAIN, STATING THAT THE PATIENT¿S HOSPITALIZATION WAS DUE TO THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR AN UNSPECIFIED BG ISSUE ASSOCIATED WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440736 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R