BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3153450 · Received June 8, 2013

    Report

    Report Number
    2531779-2013-07891
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 14, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/01/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: VISIBLE MOISTURE WAS OBSERVED BEHIND THE DISPLAY LENS. THERE WAS NO MOISTURE IN THE BATTERY COMPARTMENT. DURING TESTING, THE PUMP DID NOT POWER ON. THE PUMP FAILED A LEAK TEST DUE TO A CRACK BETWEEN THE DISPLAY LENS AND THE CASE SEAL. THE PUMP WAS OPENED AND INTERNAL MOISTURE DAMAGE WAS FOUND.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THAT THE PUMP HAD LOST POWER AFTER BEING EXPOSED TO WATER. THE REPORTER NOTED EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT AND BEHIND THE DISPLAY SCREEN. THERE WAS REPORTEDLY NO DAMAGE TO THE PUMP OR BATTERY COMPARTMENT. 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
    257183 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR