BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3252129 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12014
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 10/09/2013 WITH THE FOLLOWING RESULTS: THERE ARE NO OCCLUSION ALARMS OBSERVED IN PUMP HISTORY. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. . NO OCCLUSIONS OCCURRED DURING TESTING. AN OCCLUSION WAS INDUCED AND THE PUMP GIVES THE APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED" ALARM. PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATE. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED AND THE DISPLAY IS DIM; THE LETTERS HAVE A RED HUE. SETTING THE CONTRAST TO THE HIGHEST SETTING DID NOT IMPROVE THE DISPLAY. WHEN A TEST DISPLAY SCREEN WAS USED THE DISPLAY FUNCTIONED PROPERLY. 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 PATIENT CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: TWO DAYS AGO HER BLOOD GLUCOSE (BG) ROSE TO 480MG/DL AND SHE WAS EXPERIENCED VOMITING, CONFUSION, AND WAS DEHYDRATED. PATIENT STATES SHE WAS TRANSPORTED TO HOSPITAL. AS SHE HAD CHANGED HER SITE AND DELIVERED A CORRECTION BOLUS VIA MANUAL INJECTION PRIOR TO ARRIVAL AT HOSPITAL, AND BG WAS UNDER CONTROL, THE HOSPITAL TREATED PATIENT WITH FLUIDS AND ANTI-VOMITING MEDICATION. PATIENT STATES WHEN SHE REMOVED HER SITE, SHE HAD NOTICED THAT IT WAS BENT AND SHE HAD NOT RECEIVED ANY OCCLUSION ALARMS ALTHOUGH OCCLUSION SENSITIVITY SET TO HIGH. CUSTOMER SUPPORT (CS) CONFIRMED THAT PATIENT DID NOT RECEIVE ANY OCCLUSION ALARMS. PATIENT FEARS THAT PUMP IS NOT GIVING HER ALERTS AS IT SHOULD BE AND HAS LOST CONFIDENCE IN THE PUMP. CUSTOMER SUPPORT (CS) INSTRUCTED PATIENT THAT IF SHE FEELS UNCOMFORTABLE USING PUMP TO DISCONTINUE USE OF PUMP AND GO TO ALTERNATE FORM OF INSULIN DELIVERY. PATIENT HAS ALTERNATE FORM OF INSULIN DELIVERY SHE WILL USE UNTIL REPLACEMENT PUMP ARRIVES. THIS COMPLAINT IS BEING REPORTED AS THE PUMP FAILED TO EMIT AN OCCLUSION ALARM, AND THE PATIENT EXPERIENCED HYPERGLYCEMIA ALLEGEDLY RELATED TO THE LACK OF ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352499 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization