BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2133005 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04255
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2011 REQUESTING ASSISTANCE WITH SOME ADJUSTMENT OF THE PUMP SETTINGS. THE PATIENT'S BLOOD GLUCOSE HAD BEEN RUNNING IN THE 300-400 MG/DL CONSISTENTLY WITH SYMPTOMS OF DRY MOUTH AND FREQUENT THIRST. THE PATIENT MADE NO ALLEGATION OF A PRODUCT MALFUNCTION. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATION CONFIRMED THAT THE ANIMAS PUMP IS WORKING ACCORDINGLY. THERE WERE NO PROBLEMS IDENTIFIED WITH THE CARTRIDGE, INSULIN SITE, AND THE INFUSION SET. THE PATIENT ALLEGEDLY HAS HAD HIGH BLOOD GLUCOSE AND SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS PUMP. THE CAUSATION BETWEEN THE PATIENT ALLEGED HYPERGLYCEMIA AND THE ANIMAS PUMP CANNOT BE DETERMINE AS THERE IS NO CORRELATION. HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USER ERROR OR INCORRECT INSULIN REGIMEN, WHICH SUBSEQUENTLY MAY HAVE LED TO THE HYPERGLYCEMIC SYMPTOMS. HENCE, THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening