BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4053207 · Received September 2, 2014

    Report

    Report Number
    2531779-2014-24968
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE LEVEL OF OVER 500 MG/DL WITH MODERATE KETONES AND NAUSEA. THE REPORTER STATED THAT THE PATIENT RECEIVED AN OCCLUSION ALARM IN THE MORNING AND THAT THE PATIENT HAD OBSERVED SEVERAL CANCELLED BOLUSES IN THE HISTORY OF THE PUMP. THE REPORTER STATED THAT THE PATIENT DELIVERED ADDITIONAL BOLUSES TO COMPENSATE FOR THE CANCELLED ONES, BUT THE AMOUNT BOLUSED WAS LESS THAN NEEDED. THE REPORTER STATED THAT THE PATIENT WAS USING AN IMPROPER TECHNIQUE WITH THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT. THERE WAS ALLEGED MISUSE OF THE CARTRIDGES, BUT THE REPORTER INSISTED ON THE PUMP'S RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533751 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening