BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3831326 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14699
    Event Type
    Injury
    Date Received
    May 24, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED TO BE RETURNED TO ANIMAS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/21/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/07/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY WAS ON 05/20/2014. THE TOTAL DAILY DOSES ADDED UP AND EQUALED THE DAILY PROGRAMMED BASAL TARGET. THERE WAS A 2 HOUR UNACKNOWLEDGED ¿144¿ WARNING OBSERVED ON 05/18/2014 WHICH COULD BE DUPLICATED DURING THE INVESTIGATION. THE PUMP GAVE THE PROPER VISIBLE AND AUDIBLE ALERT AND REFLECTED 24U AFTER A 24 HOUR DURATION TEST SET ON 1U/HR BASAL. THE PRODUCT PERFORMED WITHIN SPECIFICATIONS. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT WHILE USING THE PUMP. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE WAS 531 MG/DL WITH SYMPTOMS OF MODERATE KETONES, THIRST, NAUSEA, HEADACHE, EXCESSIVE URINATION, AND PAIN IN EARS. REPORTEDLY, THE PATIENT HAD NOT RECEIVED ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, THE PATIENT¿S HEALTHCARE PROVIDER HAD NOT ADJUSTED THE PUMP SETTINGS BEFORE OR AFTER THE ALLEGED EVENT, AND THE PATIENT REMAINED ON THE PUMP. TROUBLESHOOTING DETERMINED THAT THERE WERE NO CANCELED BOLUSES IN THE HISTORY AND THE TOTAL DAILY DOSES MATCHED THE PROGRAMMED ACTIVE BASAL PROGRAM SETTING INDICATING THE PUMP WAS WORKING PROPERLY AT THE TIME OF THE ALLEGED EVENT. IT WAS ALSO DETERMINED THAT THE PATIENT HAD EXPERIENCED A CHANGE IN STRESS / PAIN LEVEL AND HAD NOT RESPONDED TO AN ALARM IN A TIMELY MANNER. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA ASSOCIATED WITH USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309660 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening