BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071145 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02936
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED THAT ONE INSTANCE OF REBOOTING HAD OCCURRED, WHICH COULD NOT BE DUPLICATED ON INVESTIGATION. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE PUMP HISTORY. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY, AND THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP, BATTERY COMPARTMENT, OR TO THE POWER CIRCUIT. UNRELATED TO THE POWER LOSS ALLEGATION, 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.

    Description of Event or Problem · 1

    THE REPORTER REPORTED, THE PUMP LOST POWER AND SELF-REBOOTED. THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS DUE TO THIS PUMP ISSUE. TROUBLESHOOTING REVEALED THERE WERE NO CRACKS IN THE BATTERY COMPARTMENT, NO LEAKS OR CORROSION, AND THE BATTERY CAP WAS INTACT AND SECURE.

    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 16 YR