BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3161640 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08054
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    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. DURING TESTING, THE PUMP DID NOT POWER ON. THE PUMP FAILED A LEAK TEST DUE TO A CRACK IN THE PUMP CASING NEAR THE RIGHT CORNER OF THE DISPLAY LENS. THE PUMP WAS OPENED AND INTERNAL MOISTURE DAMAGE WAS FOUND.

    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 CONFIRMED EVIDENCE OF MOISTURE BEHIND THE DISPLAY AND DENIED ANY DAMAGE TO THE BATTERY COMPARTMENT OR CAP. 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
    261993 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR