BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222554 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10427
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE ISSUE OF INACCURATE DELIVERY WAS NOT DUPLICATED DURING THE INVESTIGATION. 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.

    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 WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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 REPORTER CONTACTED ANIMAS ALLEGING THAT THE PREVIOUS WEEKEND THE PATIENT¿S BLOOD GLUCOSE (BG) WAS RUNNING HIGH AND THE PATIENT ENDED UP GOING TO THE HOSPITAL ON (B)(6) 2013 WITH DIABETIC KETOACIDOSIS. THE PATIENT¿S BG UPON ADMISSION TO THE HOSPITAL WAS REPORTEDLY 630 MG/DL. THE PATIENT WAS REPORTEDLY ADMITTED TO THE CCU AND PLACED ON AN INSULIN DRIP, AND WAS RELEASED ON (B)(6) 2013. THE REPORTER NOTED THAT THE SITE/SET WAS CHANGED MULTIPLE TIMES BUT SHE WAS NOT SURE IF ANY OF THE CANNULAS WERE BENT OR KINKED. THE REPORTER NOTED THAT THE PATIENT¿S BGS ELEVATED AGAIN AFTER BEING DISCHARGED FROM THE HOSPITAL. THE PATIENT REMAINED ON THE PUMP FOR BASAL DELIVERY AFTER DISCHARGE BUT WAS GIVEN CORRECTION INJECTIONS TO CORRECT BGS. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) WAS REPORTEDLY CONTACTED AND THE PATIENT WAS ADVISED TO COME OFF THE PUMP. THE PATIENT¿S HCP REPORTEDLY DOES NOT THINK THE PUMP IS DELIVERING APPROPRIATELY. THE REPORTER NOTED THAT PUMP SETTINGS WERE CHANGED WHILE THE PATIENT WAS IN THE HOSPITAL. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. TROUBLESHOOTING INDICATED THE PUMP WAS DELIVERING AS PROGRAMMED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION AND BASED ON THE ALLEGATION BY THE HCP THAT THE PUMP WAS NOT DELIVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321562 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| L| R