BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223514 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10506
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/02/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/12/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. THE COMPLAINT OF THE UNRESPONSIVE KEYPAD BUTTONS WAS NOT ABLE TO BE DUPLICATED; ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, THE KEYPAD WAS REMOVED AND NO EVIDENCE OF CONTAMINATION WAS FOUND UNDER ANY KEY CONTACTS. MOISTURE WAS OBSERVED ON THE KEYPAD FLEX CONNECTOR. THERE WAS NO MOISTURE CORROSION IN THE BATTERY COMPARTMENT. DURING TESTING, A DISPLAY LENS LEAK WAS FOUND. THE PUMP COVER WAS REMOVED AND VISIBLE MOISTURE CORROSION WAS FOUND ON THE PUMP¿S INTERNAL COMPONENTS. 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

    ON (B)(6) 2013, THE REPORTER STATED THAT AFTER THE PATIENT SWAM WITH THE PUMP A CS ALARM WAS RECEIVED. THE REPORTER CLAIMED THAT THE PUMP WAS REBOOTED AND THE DISPLAY SCREEN WAS FROZEN. THE PUMP DID NOT RESPOND TO KEYPAD BUTTON PRESSES. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT IS BEING REPORTED BECAUSE THE KEYPAD ISSUE WAS NOT RESOLVED DURING TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321798 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR