BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2970061 · Received February 20, 2013

    Report

    Report Number
    2531779-2013-01944
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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.

    Description of Event or Problem · 1

    ON (B)(64) 2013, THE PATIENT CONTACTED ANIMAS VIA E-MAIL STATING THAT SHE HAS BEEN IN AND OUT OF THE HOSPITAL SINCE (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED. CUSTOMER TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO REACH THE PATIENT FOR ADDITIONAL INFORMATION, WITHOUT SUCCESS. IT IS UNKNOWN AT THIS TIME IF THE REPORTED INCIDENT IS RELATED TO DIABETES OR NOT, OR IF THE PUMP WAS A CAUSE OR CONTRIBUTOR IN THE REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT REQUIRING MEDICAL INTERVENTION FOR AN UNKNOWN ISSUE WHICH MAY OR MAY NOT BE RELATED TO DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73589 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| R