BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191318 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09055
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 08/13/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/18/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX HISTORY SHOWED ONE UNEXPLAINED POWER EVENT OCCURRING. THE PUMP AND BATTERY CAP WERE EXAMINED AND NO VISIBLE DAMAGE WAS FOUND. THE BATTERY CAP WAS TESTED AND WAS CONFIRMED TO BE WITHIN SPECIFICATIONS. THE BATTERY CAP WAS INSERTED AND THE PUMP POWERED ON APPROPRIATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER INTERRUPTION. THE PUMP WAS OPENED AND NO INTERNAL MOISTURE DAMAGE OR DEFECTS WERE FOUND. THE ISSUE WAS OBSERVED IN THE PUMP HISTORY BUT COULD NOT BE DUPLICATED DURING TESTING. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP HAD POWERED OFF AT RANDOM AND WOULD NOT POWER BACK ON AFTER BATTERY CHANGES. 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
    291202 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR