BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3123805 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06858
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/23/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES SHOWED A REPLACE BATTERY ALARM OCCURRED AT 20:53 ON (B)(6) 2013. THE BATTERY VOLTAGE AT THE TIME OF THE ALARM WAS LOW. THE ALARM WENT UNCONFIRMED, DISCHARGING THE BATTERY AND CAUSING THE PUMP TO REBOOT. VISUAL INSPECTION REVEALED NO DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP WITH NO YELLOW O-RING SHOWING. THE BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE PUMP COVER WAS REMOVED AND NO INTERNAL DAMAGE WAS FOUND. INVESTIGATION DETERMINED THAT THE ALLEGED POWER ISSUE WAS CAUSED BY INAPPROPRIATE RESPONSE TO AN APPROPRIATELY EMITTED ALARM.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) 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
    225789 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR