BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6111173 · Received November 17, 2016

    Report

    Report Number
    2531779-2016-31709
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    October 24, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER CAREGIVERS

    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 07-MAR-2018 - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 15-FEB-2018 WITH THE FOLLOWING FINDINGS: DURING THE INVESTIGATION, NO UNUSUAL ALARMS WERE OBSERVED IN THE ALARM HISTORY. THE PUMP WAS FOUND TO BOOT TO THE VERIFY SCREEN WITH NO ERRORS. A 24-HOUR DURATION TEST WAS SUCCESSFULLY COMPLETED. ALL KEYS RESPONDED APPROPRIATELY. THE INVESTIGATORS WERE UNABLE TO DUPLICATE THE ¿PUMP NO LONGER WORKS¿ COMPLAINT. 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) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP NO LONGER FUNCTIONED PROPERLY. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE MAY IMPACT INSULIN DELIVERY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762344 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR