BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2831507 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13580
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2012 REPORTING THAT THE PATIENT WAS HAVING A SEIZURE AND UNRESPONSIVE. THE REPORTER STATED THAT THE BLOOD GLUCOSE WAS CHECKED AND THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL WAS 27MG/DL. THE PATIENT WAS GIVEN A GLASS OF ORANGE JUICE AND HIS SEIZURE STOPPED. THE REPORTER STATED THAT 911 WAS NOT CALLED AND THE PATIENT WAS NOT TAKEN TO THE HOSPITAL. CUSTOMER SUPPORT AND THE REPORTER REVIEWED THE HISTORY SETTINGS AND SEEM TO BE SET APPROPRIATELY. HOWEVER, THE PATIENT AND THE REPORTER ARE GUESSING AT WHAT THE BOLUS AMOUNTS SHOULD BE AND THEY WERE ENCOURAGED TO CALL THEIR HEALTHCARE PROFESSIONAL TO OBTAIN THE SETTINGS. THE REPORTER STATED THAT THE INSULIN SENSITIVE FACTOR MAY NOT HAVE BEEN SET PROPERLY, IT WAS SET TO 1UNIT TO 600MG/DL. THE REPORTER STATED THAT THE PATIENT WAS REUSING CARTRIDGES. CUSTOMER SUPPORT CONCLUDED DISEASE MANAGEMENT-TRAINING MISUSE DUE TO THE PATIENT NOT KNOWING WHAT THE PUMP SETTINGS SHOULD BE AND RE-USING CARTRIDGES. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPOGLYCEMIC EVENT DUE TO UNKNOWN ORIGIN.

    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 71 YR Life Threatening