BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3162106 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08066
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE RECORDED ON (B)(6) 2013. THERE WERE NO ALARMS ASSOCIATED WITH THE COMPLAINT IN THE HISTORY. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. DURING TESTING, 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. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, STATING THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE LEVELS BETWEEN 40 AND 300 MG/DL. THE REPORTER INDICATED THAT THE PATIENT WAS DIZZY AND HUNGRY WITH THE LOW BLOOD GLUCOSE AND DID NOT FEEL WELL WITH THE ELEVATED BLOOD GLUCOSE. THE PUMP WAS REVIEWED WITH THE REPORTER AND CONFIRMED THAT THE BASAL WAS PROGRAMMED CORRECTLY. THE REPORTER CONFIRMED THAT THERE WAS NO AIR SEEN IN THE CARTRIDGE OR TUBING AND THE CONNECTIONS WERE SECURE WITH NO NOTED LEAKS. THE REPORTER WAS ADVISED THAT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION RELATED TO THE COMPLAINT. THE REPORTED ELEVATED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262310 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening