BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4914674 · Received July 15, 2015

    Report

    Report Number
    2531779-2015-23748
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    June 29, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 10/05/2015, DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/15/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS RETURNED WITH ALL OF THE KEYPAD BUTTONS RESPONDING INTERMITTENTLY. THERE WAS NO PHYSICAL DAMAGE ON THE KEYPAD. THE KEYPAD WAS REMOVED AND THERE WAS CONTAMINATION FOUND UNDER ALL THE BUTTON CONTACTS. UNRELATED TO THE ORIGINAL ISSUE, IT WAS NOTED THAT WHEN THE PUMP WAS POWERED ON, THE DISPLAY APPEARED TO BE DIM AND DISCOLORED. THERE WAS MOISTURE OBSERVED IN THE BATTERY COMPARTMENT AND A LEAK TEST WAS PERFORMED AND FAILED INDICATING A BATTERY COMPARTMENT LEAK. IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE PUMP WAS OPENED AND THERE WAS NO MOISTURE FOUND. THE THREADS ON THE BATTERY CAP WERE STRIPPED AND UNABLE TO BE SECURED. 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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE DOWN ARROW REPORTEDLY WAS UNDER-RESPONSIVE. 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
    458549 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR