BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3105018 · Received May 10, 2013

    Report

    Report Number
    2531779-2013-06153
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Report Date
    January 2, 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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/10/2013 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A REBOOT, TIME AND DATE RESETS, AND CS 078-0009, CS 078-0008 , AND CS 064-0008 CALL SERVICE ALARMS. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED; HOWEVER THE BATTERY CAP WAS INTACT AND SECURED PROPERLY TO THE PUMP. THE BATTERY CAP CONTACT DIMENSIONS WERE ALSO WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS AND THE REWIND, LOAD, AND PRIME STEPS WERE COMPLETED SUCCESSFULLY WITH NO POWER INTERRUPTIONS OR CALL SERVICE ALARMS NOTED. DURING TESTING, PUMP WAS POWERED OFF AND THE TIME AND DATE RESET TO FACTORY SETTINGS WHEN THE PUMP WAS BOOTED. THE DISPLAY SCREEN ALSO APPEARED FADED AND DISCOLORED. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF MOISTURE INGRESS WAS FOUND ON MULTIPLE INTERNAL COMPONENTS. THE INTERNAL CLOCK BATTERY WAS ALSO FOUND TO HAVE FAILED. THE INITIAL INVESTIGATION DID NOT INCLUDE TESTING FOR THIS COMPLAINT, AND THE PUMP WAS NO LONGER AVAILABLE FOR FURTHER INVESTIGATION.

    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, IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND SLOW TO RESPOND. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206357 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR