BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760435 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10656
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 8, 2014
    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

    FOLLOW-UP #1: DATE OF SUBMISSION 05/16/2014. DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/08/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON WITH NO DISPLAY. THE AUDIBLE AND VIBRATORY FEATURES FUNCTIONED APPROPRIATELY. THE PUMP WAS OPENED AND THE DISPLAY WAS FOUND TO BE CRACKED AND DAMAGED. WHEN THE DISPLAY WAS REPLACED BY A TEST DISPLAY, THE DISPLAY FUNCTIONED PROPERLY. UNRELATED TO THE DISPLAY ISSUE, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240965 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR