BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2954940 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01666
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY APPEARS TO BE INACCURATE DUE TO THE TIME AND DATE BEING SET INCORRECTLY. A REVIEW OF THE PUMP HISTORIES INDICATE THAT THE TIME/DATE SETTING WAS MANUALLY CHANGED FROM (B)(6) 2007 TO (B)(6) 2014, AND THEN FROM (B)(6) 2014 TO (B)(6) 2013 AFTER A REBOOT. THE TOTAL DAILY DOSE HISTORY ALSO APPEARED ERRATIC DUE TO THE TIME AND DATE ISSUE. THE PUMP PASSED EZPRIME STEPS CORRECTLY AND WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. THE PUMP PASSED 29 HOUR FLOW ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. TROUBLESHOOTING FOUND THAT THE TIME AND DATE RESET TO DEFAULT WITH A BATTERY CHANGE. THE TIME RESET ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 501 MG/DL WITH NO SIGNS OR SYMPTOMS; THE DATE OF THE HIGH BLOOD GLUCOSE WAS NOT PROVIDED. THE REPORTER INDICATED THAT THE PATIENT WAS CHECKING BLOOD GLUCOSE LEVELS AND BOLUSING APPROPRIATELY. A REVIEW OF PUMP HISTORY INDICATED THAT DURING THE LAST BATTERY CHANGED THE TIME AND DATE REVERTED TO DEFAULT AND THE TIME WAS NOT CORRECTED UPON REBOOT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59453 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening