BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243029 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11748
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT SHE HAD DKA WHILE ON INSULIN PUMP THERAPY. THE PATIENT WAS TREATED FOR HYPERGLYCEMIA AT THE TIME OF CONCERN. THERE WAS NO EVIDENCE OR ALLEGATION OF A PRODUCT MALFUNCTION ASSOCIATED WITH THE REPORTED ISSUE. ANIMAS MADE 3 ATTEMPTS TO CONTACT THE PATIENT BACK FOR MORE INFORMATION. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALLBACK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION FOR DKA WHILE ON INSULIN PUMP THERAPY. ALTHOUGH, THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, THE SUBJECT INSULIN PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE REPORTED INCIDENT DUE TO INTENTIONAL MISUSE OR USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343114 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R