BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232827 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11170
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/23/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (B)(4) 2013 WITH THE FOLLOWING FINDINGS: MOISTURE WAS VISIBLE BEHIND THE DISPLAY LENS. A LEAK TEST WAS PERFORMED AND A CRACK WAS FOUND IN THE PUMP CASE. THE PUMP CASE WAS REMOVED AND INTERNAL MOISTURE DAMAGE WAS OBSERVED. 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 BLANK DISPLAY SCREEN ISSUE. AFTER EXPOSURE TO MOISTURE, THE SCREEN WENT BLANK. THE ISSUE OCCURRED A FEW MINUTES PRIOR TO THE COMPLAINT. 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
    333238 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR