BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3253771 · Received July 30, 2013

    Report

    Report Number
    2531779-2013-12077
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) 2013 THE REPORTER CONTACTED ANIMAS REQUESTING AN UPGRADE AND ALLEGED THAT THE PATIENT HAS BEEN IN THE HOSPITAL AND HAS BEEN OFF THE PUMP ¿FOR SOME TIME NOW¿. THE REPORTER STATED THAT THE PATIENT HAS BEEN IN AND OUT OF THE HOSPITAL AND THE HOSPITAL SUGGESTED THAT THE PATIENT DISCONTINUE THE PUMP. NO FURTHER INFORMATION WAS PROVIDED. CUSTOMER TECHNICAL SUPPORT HAS ATTEMPTED TO FOLLOW UP WITH THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT HAS BEEN IN THE HOSPITAL AND IT IS UNKNOWN IF THE PUMP WAS A CAUSE OR CONTRIBUTOR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355032 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R