BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3092497 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05870
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, INFORMATION FOR THE COMPLAINT IS OVERWRITTEN. THE BLACK BOX STARTS ON (B)(6) 2014. THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE (B)(6) 2013 AND ALL HISTORIES AND BLACK BOX DATA FOR EVENT HAVE BEEN OVERWRITTEN. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOWS NO ALARMS RELATED TO THE COMPLAINT. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USER PROGRAMMED BASAL RATE. PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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

    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 (PATIENT'S MOTHER) CONTACTED ANIMAS ON (B)(6) 2013, BY LEAVING A MESSAGE THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL THAT MORNING FOR MILD DIABETIC KETOACIDOSIS. ANIMAS CUSTOMER TECHNICAL SUPPORT WAS ABLE TO FOLLOW UP WITH THE REPORTER ON (B)(4) 2013. THE REPORTER STATED THAT THE PATIENT WAS STILL HOSPITALIZED AT THAT TIME. THE REPORTER STATED THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED ELEVATED BG OF OVER 400 MG/DL DUE TO NOT CHANGING OUT THE INFUSION SET WHEN IT NEEDED TO BE CHANGED. AFTER THE INFUSION WAS CHANGED OUT BY THE PATIENT'S MOTHER, THE BG DECREASED TO 287 MG/DL WITH SMALL KETONES ON (B)(6) 2013; HOWEVER, THE PATIENT BEGAN VOMITING AND THEN WENT TO THE LOCAL EMERGENCY ROOM. AT THE HOSPITAL, A DIABETIC EDUCATOR REPORTEDLY EXAMINED THE PATIENT'S INFUSION SITE AND NOTED "A LOT OF AIR IN THE TUBING" BELIEVED TO BE THE RESULT OF THE PATIENT'S MOTHER DRAWING INSULIN OUT OF AN INSULIN INJECTION PEN TO FILL THE CARTRIDGE FOR THE INSULIN PUMP. DURING FOLLOW UP ON (B)(6) 2013, THE REPORTER STATED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 AND WAS BACK ON INSULIN PUMP THERAPY AND DOING WELL WITHOUT ANY CURRENT ISSUES. THIS COMPLAINT IS BEING REPORTED BECAUSE IMPROPER TECHNIQUE WAS USED FOR FILLING THE CARTRIDGE AND CHANGING OUT THE INFUSION SITE, WHICH RESULTED IN ELEVATED BG REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193708 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| L| R