BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191294 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09058
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 09/13/2013 DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013WITH THE FOLLOWING FINDINGS:MULTIPLE REBOOTS WERE NOTED IN THE BLACK BOX HISTORY. NO DAMAGE WAS FOUND TO BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT RETURNED WITH PUMP FOR INVESTIGATION. A BATTERY TEST CAP WAS USED FOR TESTING PURPOSES AND WAS FOUND TO TIGHTLY SECURE TO THE PUMP. DURING TESTING, THE PUMP POWERED ON NORMALLY WITH NO ALARMS NOTED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS NOTED. MOISTURE WAS FOUND IN DISPLAY SCREEN. THE BOLUS BUTTON WAS FOUND TO BE LEAKING DURING A LEAK TEST. THE PUMP COVER WAS OPENED AND MOISTURE DAMAGE FOUND ON THE PCB. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS IN THE WATER WITH PUMP, THEY FELT PUMP VIBRATING WHILE SWIMMING. THE REPORTER STATED, HE GOT OUT OF THE WATER AND TOOK THE PUMP OFF. THE REPORTER STATED THAT THE PUMP WAS STUCK ON VERIFY SCREEN AND RESET TIME AND DATE TO FACTORY SETTINGS. THE REPORTER STATED THAT THERE WAS MOISTURE IN THE CARTRIDGE COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE MOISTURE INGRESS POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289827 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR