BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091833 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03499
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/22/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/24/2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. CORRECTION: IT WAS REPORTED THAT THE TIME AND DATE HAD RESET TO DEFAULT FACTORY SETTINGS UPON ROUTINE BATTERY CHANGE. THIS MALFUNCTION IS GENERALLY NOT REPORTABLE BECAUSE THE PUMP DISPLAYS THE "VERIFY" SCREEN AFTER IT IS REBOOTED, AND THE TIME AND DATE MUST BE SET TO CONFIRM THE "VERIFY" SCREEN. THE ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S FATHER, REPORTED THE INSULIN PUMP RESET TO THE FACTORY DATE/TIME SETTINGS AFTER THE BATTERY WAS REPLACED. TROUBLESHOOTING ALLOWED THE REPORTER TO RESET THE PUMP TO THE CORRECT DATE/TIME. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    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 10 YR