BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021470 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03079
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PATIENT WAS HOSPITALIZED WITH DKA AND A BLOOD GLUCOSE LEVEL OF 1350MG/DL. THE PATIENT WAS REPORTEDLY HOSPITALIZED ON (B)(6) 2013. THE PUMP HISTORY DOES SHOW THAT BOLUSES WERE GIVEN ON THE DAY PRIOR TO THE HOSPITALIZATION. THE PATIENT'S BASAL RATE IS REPORTEDLY SET TO 12 UNITS/HOUR. THE PUMP HISTORY INDICATES THAT THE PUMP DELIVERED 10.1 UNITS OF BASAL INSULIN ON 2(B)(6) AND 10.625 UNITS ON (B)(6). THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA AND DKA AND THAT THE PUMP MAY HAVE DELIVERED LESS THAN THE PROGRAMMED AMOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124487 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R