BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021671 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03095
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/24/2013. DEVICE EVALUATION:THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/14/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THAT INFORMATION FROM THE REPORTED EVENT DATE WAS OVERWRITTEN IN THE BLACK BOX. THE LAST BASAL DELIVERY WAS ON 08/06/2013; AVAILABLE DATA SHOWS NO ACTIVITY OUTSIDE OF NORMAL USE. THE TOTAL DAILY DOSES CORRECTLY REFLECT THE PROGRAMMED BASAL PROGRAM. THE PUMP POWERED UP AND DISPLAYED THE ¿VERIFY¿ SCREEN. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS, WITH NO DELIVERY INTERRUPTION OCCURRING. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST SUCCESSFULLY. 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

    CUSTOMER TECHNICAL SUPPORT DETERMINED THAT THE ALARM THAT WAS EMITTED WAS RELATED TO AN INFUSION SET ISSUE, AND INSTRUCTED THE PATIENT TO CHANGE THE INFUSION SET. ANIMAS DOES NOT MANUFACTURE THE INFUSION SETT BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER. THE PUMP WAS FOUND TO BE ALARMING APPROPRIATELY TO ALERT THE USER OF AN ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. 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

    ON (B)(4) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE WENT TO THE HOSPITAL FOR BLOOD GLUCOSE (BG) OVER 600MG/DL WITH DRY MOUTH, SWEATING, AND SHAKING AND WAS CURRENTLY WAITING IN THE EMERGENCY ROOM TO SEE A DOCTOR. THE PUMP HAD REPORTEDLY EMITTED AN ALARM WHILE THE PATIENT WAS TRYING TO BOLUS. DUE TO THE ALARM, THE PATIENT WAS NOT ABLE TO COMPLETE THE BOLUS AND REPORTEDLY GAVE HERSELF A CORRECTION INJECTION INSTEAD. IT IS UNCLEAR AT THIS TIME IF THE REPORTED BG EXCURSION WAS RELATED TO THE ALARM OR IF THE PATIENT'S BG HAD ALREADY BEEN ELEVATED PRIOR TO THE ALARM. THE PATIENT REPORTEDLY HAD NOT CHANGED THE SITE/SET IN RESPONSE TO THE ALARM OR TO THE BG EXCURSION. THE PATIENT WAS ADVISED TO CHANGE THE SITE/SET. THE PATIENT CONFIRMED THAT THE PUMP'S TIME AND DATE WERE CORRECT AND THE BASAL RATES WERE SET CORRECTLY. ADDITIONAL PUMP TROUBLESHOOTING COULD NOT BE COMPLETED AS THE PATIENT WAS IN THE ER WAITING TO SEE A DOCTOR. CUSTOMER TECHNICAL SUPPORT (CTS) MADE MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE PATIENT TO COMPLETE TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WHILE USING INSULIN PUMP THERAPY AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124248 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening| R