BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211215 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09851
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/20/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON WITH AUDIBLE AND VIBRATORY FUNCTION. THE PUMP HISTORY WAS REVIEWED AND SHOWED A NO IOB (INSULIN ON BOARD) REMAINING WARNING HAD OCCURRED ON (B)(6) 2013. FOR INVESTIGATION PURPOSES THE USER¿S BASAL SETTINGS AND A DURATION PERIOD OF 4.0 HOURS WAS ENTERED INTO THE PUMP. A 2.20U EZCARB BOLUS WAS PERFORMED AND THE BOLUS WAS CORRECTLY REFLECTED ON THE IOB STATUS SCREEN. AT THE END OF THE 4.0 HOUR DURATION PERIOD, THE IOB STATUS SCREEN CORRECTLY REFLECTED 0.00U, INDICATING THAT THE IOB CALCULATION WAS FUNCTIONING PROPERLY. UNRELATED TO THE COMPLAINT, A CRACK NEAR THE CASE SEAL OF THE BATTERY COMPARTMENT WAS OBSERVED. ALSO UNRELATED TO THE COMPLAINT, THE FORCE SENSOR CALIBRATION WAS FOUND OUT OF REQUIRED SPECIFICATIONS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. THE INSULIN ON BOARD CALCULATION ISSUE 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INSULIN ON BOARD CALCULATION) ISSUE. THE REPORTER INDICATED THAT THE INSULIN ON BOARD WAS REMAINING FOR LONGER THAN EXPECTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309838 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR