BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3122314 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06802
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE MADE AT THIS TIME.

    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: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE LAST BASAL DELIVERY WAS ON (B)(4) 2013 AND THE LAST BOLUSES WERE DELIVERED ON (B)(4) 2013 AT 7:30 AM AND 8:30 AM. THE INSULIN ON BOARD WAS SET TO A FOUR HOUR EXPANSION. NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED IN THE HISTORY AND THE TOTAL DAILY DOSES ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATE. DURING TESTING, THE PUMP WAS TESTED FOR 24 HOURS WITH NO ISSUES. BOLUSES WERE SUCCESSFULLY EXECUTED USING THE NORMAL, EZ CARB, EZ BG, AND COMBO BOLUS SETTINGS; THE BOLUSES WERE RECORDED IN THE PUMP¿S HISTORY IN THE CORRECT TIME AND ORDER. THE INSULIN ON BOARD FUNCTION WAS TESTED AND FOUND TO WORKING ACCURATELY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. THE KEYPAD BUTTONS WERE TESTED AND ALL RESPONDED PROPERLY. THE PUMP¿S COVER WAS OPENED AND NO DAMAGE WAS FOUND TO THE INTERNAL CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE REPORTER (ALSO THE MOM) CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT HAD BEEN DOSED THIS MORNING BEFORE SCHOOL AND WHEN THE PATIENT WAS AT SCHOOL ABOUT 9AM THE SCHOOL NURSE CALLED AND STATED THAT THE INSULIN ON BOARD (IOB) HAD 1.07 UNITS ON BOARD. THE PATIENT DENIED GIVING A BOLUS. THE REPORTER STATED THAT THE HISTORY SHOWED A BOLUS OF 1/1 UNIT GIVEN AT 8:29AM THIS MORNING AND AT 12:50PM ABOUT 20 MINUTES AFTER A BOLUS WAS GIVEN FOR LUNCH ANOTHER 1.05/1.05 UNITS DELIVERED VIA NORMAL BOLUS. THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 50MG/DL AND WAS TREATED WITH JUICE AND NOW THE BG WAS 105MG/DL. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE REPORTER STATED THAT THE PATIENT IS RUNNING LOW FOR A FEW DAYS AND THINKS THAT THE PUMP IS GIVING A REPEAT BOLUS OF THE ONE THAT WAS GIVEN ONE HOUR LATER- THEREFORE CAUSING LOW BG'S. THIS REPORT IS BEING MADE DUE TO THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224249 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR