BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080494 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05368
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: ON (B)(6) 2013, ABOUT 10 PM, HE INSERTED A NEW INFUSION SET. WHEN THE SET WAS REMOVED ON (B)(6) 2013, ABOUT 2 PM, IT WAS FOUND TO BE BENT. HE REPORTS NO OCCLUSION ALARM FOUND IN ALARM HISTORY. SENSITIVITY IS SET ON H. THE PATIENT'S FATHER STATES THE BLOOD GLUCOSE (BG) LEVELS WERE IN THE 500-600 MG/DL RANGE THE MORNING OF (B)(6) 2013, AND THEY CHANGED THE SET AGAIN, AT WHICH TIME THEY NOTED THE BENT CANNULA. THE SET WAS CHANGED ONCE MORE, AND THE SITE MOVED FROM ABDOMEN TO ARM. THE BG AT 5 PM WAS STILL OVER 600 MG/DL AND AN INJECTION WAS GIVEN PER HEALTH CARE PROVIDER (HCP) INSTRUCTIONS. BG WAS 560 MG/DL AT 6:50 PM AND WAS DOWN TO 530 MG/DL AT THE END OF THE CALL. PATIENT REPORTS SYMPTOMS OF EXCESSIVE THIRST AND FREQUENT URINATION. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP FAILED TO EMIT AN OCCLUSION ALARM WHEN THE CANNULA WAS BENT, AND BECAUSE THE HYPERGLYCEMIA DID NOT RESPOND WITH REPEATED CHANGES OF SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182529 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening