BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222437 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10407
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THAT END OF PUMP USE WAS ON (B)(6) 2013; THE LAST BASAL AND THE LAST BOLUS WERE RECORDED ON THIS DATE. THERE WERE NO ALARMS RELATED TO THE COMPLAINT RECORDED IN BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST SUCCESSFULLY. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION; THERE WAS NO DEFECT FOUND. 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 PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAS HAD ELEVATED BLOOD GLUCOSE (BG) EVERY DAY SINCE (B)(6) 2013. THE PATIENT REPORTED BG UP TO 400 MG/DL WITH MODERATE LETHARGY AND EXTREME THIRST. THE PATIENT REPORTED BGS REMAIN ELEVATED DESPITE DELIVERING BOLUSES. THE PATIENT REPORTEDLY CHANGES HER SITE ALMOST EVERY DAY. THE PATIENT DENIED NEW MEDICATIONS, NEW ACTIVITIES OR STRESSORS, AND DENIED DIET CHANGES. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. THE PATIENT DENIED ANY SITE OR SET ISSUES AND DEMONSTRATED APPROPRIATE SITE CHANGES AND ROTATION. THE PATIENT WAS REPORTEDLY OFF THE PUMP AND ON INSULIN INJECTIONS AT THE TIME OF THE CALL TO ANIMAS. TROUBLESHOOTING INDICATED THAT THE PUMP WAS DELIVERING AS PROGRAMMED, HOWEVER THE PATIENT INSISTED THAT THE PUMP BE REPLACED. THE PATIENT STATED SHE HAD SETTINGS ADJUSTMENTS SIX MONTHS PRIOR AND HER MD DID NOT FEEL SHE NEEDED ADDITIONAL SETTINGS ADJUSTMENTS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY AND BASED ON THE INSISTENCE THAT THE PUMP BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322765 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening