BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3884886 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17629
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/08/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED A REBOOT ON (B)(6) 2014 AT 18:24. WHEN THE PUMP WAS POWERED BACK ON, THE TIME AND DATE RESET TO THE DEFAULT SETTING DUE TO AN UNRELATED INTERNAL CLOCK BATTERY ISSUE. THE TIME WAS SET INCORRECTLY TO 07:13; THE DATE WAS SET TO (B)(6) 2014. THE INCORRECT TIME LEAD TO THE TDD¿S TO APPEAR TO BE INACCURATE; CAUSING A NO DELIVERY, EXCEEDS TOTAL DAILY DOSE WARNING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ERRORS, ALARMS, OR WARNINGS. THE COMPLAINT WAS NOT DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. 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
    360082 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR