BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6197893 · Received December 22, 2016

    Report

    Report Number
    2531779-2016-34520
    Event Type
    Injury
    Date Received
    December 22, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER WAS UNABLE TO PROVIDE A SPECIFIC BLOOD GLUCOSE AMOUNT, BUT STATED THAT THEY HAD A ¿HI¿ READING ON THEIR METER, INDICATING A BLOOD GLUCOSE OF OVER 600 MG/DL. THERE WERE NO REPORTED SYMPTOMS OF HYPERGLYCEMIA AT THE TIME OF THE CALL. THE PATIENT HAD REMAINED ON THE PUMP AT THE TIME OF THE CALL. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER WAS UNABLE TO COMPLETE TROUBLESHOOTING AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850567 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening