BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3120560 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06728
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/15/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/17/2013 WITH THE FOLLOWING FINDINGS:THE PUMP POWERED ON WITH A RED LINE IN THE DISPLAY SCREEN; THE DISPLAY WAS READABLE. THE PUMP CASING WAS REMOVED AND THE DISPLAY WAS REPLACED WITH A TEST DISPLAY. THE TEST DISPLAY DID NOT HAVE ANY LINES THROUGH IT. INVESTIGATION DETERMINED THAT A FAILED DISPLAY FLEX WAS THE CAUSE OF THE LINE ISSUE. 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 REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY) ISSUE. REPORTEDLY, THE DISPLAY SCREEN HAS A RED LINE EXTENDING HALFWAY ACROSS THE SCREEN AND A BLUE LINE AT THE BOTTOM OF THE SCREEN. 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
    221374 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR