BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3240675 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11580
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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 (B)(4)WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/22/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/09/2013 WITH THE FOLLOWING FINDINGS: THE METER REMOTE WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THE PUMP HISTORY SHOWED PRIME AND FILL CANNULA EVENTS ON 07/08/2013; THE HISTORY INDICATED THAT THE PUMP CONTINUED TO DELIVER INSULIN WITH THE SAME CARTRIDGE UNTIL THE NEXT PRIME AND FILL CANNULA EVENT ON 07/14/2013. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS OCCURRING; THE PUMP WAS CONFIRMED TO BE INDICATED THE CORRECT INSULIN REMAINING DURING TESTING. A PRIME AND FILL CANNULA WERE PERFORMED DURING TESTING AND CORRECTLY RECORDED IN THE PUMP HISTORY. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT¿S BLOOD GLUCOSE LEVELS ELEVATED TO HI ON THE METER (OVER 33.3 MMOL/L) WITH LARGE KETONES. THE REPORTER STATED THAT THE SITE WAS CHANGED MULTIPLE TIMES AND INSULIN WAS GIVEN VIA INJECTION AND THE PATIENT¿S BLOOD GLUCOSE DECREASED TO 15 MMOL/L. THE PUMP HISTORY WAS REVIEWED AND NO PRIME RECORDS WERE RECORDED FOR DATES BETWEEN (B)(6) 2013. THE REPORTER INDICATED THAT THIS WAS INCORRECT AS THE SITE WAS CHANGED DURING THAT TIME AND THEY WERE CERTAIN THAT THE PUMP WAS PRIMED DURING THE SITE CHANGES. THE REPORTER INDICATED THAT THEY WERE QUESTIONING THE PUMP¿S INSULIN DELIVERY AND THE REPORTER WAS ADVISED TO USE A BACK UP TREATMENT PLAN IF THEY WERE NOT CONFIDENT THAT THE PUMP WAS DELIVERING APPROPRIATELY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGATION OF INACCURATE INSULIN DELIVERY AND INACCURATE PUMP HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340284 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening