BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3872462 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-17002
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(6) 2014 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/31/2014 WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT, BATTERY COMPARTMENT IS CRACKED ON SIDE NEAR THREADS PUMP BOOTS TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS. AN EZBG BOLUS AND AN EZCARB BOLUS WERE MANUALLY CALCULATED; RETURNED PUMP CORRECTLY CALCULATED THE SAME UNITS. PUMP¿S BOLUS CALCULATION FEATURE FOUND TO BE FUNCTION PROPERLY. NO ALARMS RELATED TO COMPLAINT IN ALARM HISTORY. TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST. .AR THREADS AND CRACKED BETWEEN THE THREADS AND BUMPER PAD. BATTERY CAP AND CARTRIDGE CAP WERE NOT RETURNED; TEST CAPS ABLE TO ATTACH TO THE PUMP AND WERE USED TO COMPLETE TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 410MG/DL WITH SEVERE WEAKNESS AND WAS UNABLE TO WALK. THE REPORTER STATES THAT THE AMOUNT OF INSULIN RECOMMENDED BY THE PUMP IS TOO HIGH, THOUGH THE SETTINGS ARE CORRECT. REPORTER STATES THIS HAPPENS PERIODICALLY AND DENIES IT IS RELATED TO INSULIN ON BOARD. REPORTER HAS LOST CONFIDENCE IN THE PUMP, WHICH IS BEING REPLACED AT THE REPORTER'S INSISTENCE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP CANNOT BE RULED OUT AS CAUSING/CONTRIBUTING TO THE HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349262 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening