BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232616 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11140
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/11/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/24/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS UNABLE TO BE POWERED ON; THEREFORE, THE BUTTONS WERE NOT ABLE TO BE TESTED. THERE WAS MOISTURE VISIBLE IN THE DISPLAY SCREEN AND THE LEAK TEST FAILED DUE TO TWO CRACKS IN THE CASING. THE PUMP CASING WAS CRACKED IN THE UPPER AND LOWER RIGHT CORNERS BETWEEN THE LENS AND THE CASE SEAL. THE KEYPAD WAS REMOVED WITH NO DEFECT FOUND UPON INSPECTION. ALL INTERNAL SURFACES OF THE PUMP WERE COVERED WITH MOISTURE OR CORROSION. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT 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 BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW, DOWN ARROW AND OK BUTTON WERE UNRESPONSIVE AFTER SWIMMING. IT WAS ALSO NOTED THAT THERE WAS MOISTURE UNDER THE DISPLAY. 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
    336317 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR