BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3180966 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08692
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/24/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON WITH A BLANK SCREEN AND NO VIBRATION; THE PUMP WAS EMITTING AUDIBLE TONES. THERE WAS EVIDENT MOISTURE BEHIND THE DISPLAY LENS. THE PUMP FAILED A LEAK TEST DUE TO A CRACK IN THE PUMP¿S CASING. THE PUMP COVER WAS REMOVED AND THERE EVIDENCE OF MOISTURE DAMAGE INTERNALLY. 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 PATIENT REPORTED THAT THE PUMP WOULD NOT POWER ON. IT WAS SAID THAT THE PUMP EMITTED A REPLACE BATTERY ALARM PRIOR TO SHUTTING OFF. THE PATIENT DENIED DAMAGE TO THE PUMP CASING OR KEYPAD. IT WAS FURTHER REPORTED THAT THE BATTERY COMPARTMENT WAS DRY AND NOT CORRODED; THE BATTERY CAP WAS SECURE WITHOUT VISIBLE O-RING. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE PUMP AS IT COULD NOT BE TURNED ON. NO ADVERSE EVENT WAS REPORTED RELATED TO THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE POWER ISSUE COULD NOT BE RESOLVED DURING TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279819 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR