BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2880566 · Received December 19, 2012

    Report

    Report Number
    2531779-2012-14884
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 12/04/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 11/22/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOCKING. THE PUMP WAS LOCKED AND UNLOCKED DURING THE INVESTIGATION WITHOUT ANY DIFFICULTY. ALL BUTTONS RESPOND TO PRESSES APPROPRIATELY. NO DAMAGE FOUND TO KEYPAD. THE KEYPAD WAS REMOVED; NO DAMAGED/MISALIGNED CONTACTS FOUND, NO EVIDENCE OF CONTAMINATION FOUND UNDER BUTTON CONTACTS. 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 FOR EVALUATION. 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. 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) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP WAS LOCKED, NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE PATIENT TO TROUBLESHOOT THE PUMP, HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR