BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223607 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10449
    Event Type
    Malfunction
    Date Received
    July 12, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2013 WITH THE FOLLOWING FINDINGS: DURING A REVIEW OF THE PUMP¿S HISTORY, NO REBOOTS WERE OBSERVED. A VISUAL INSPECTION OF THE PUMP SHOWED VISIBLE MOISTURE BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON NORMALLY TO THE VERIFY SCREEN. THE KEYPAD BUTTONS WERE NOT RESPONDING DUE TO MOISTURE INGRESS. THE PUMP FAILED A LEAK TEST DUE TO A CRACK IN THE PUMP CASE BY THE UPPER RIGHT HAND SIDE OF THE DISPLAY SCREEN. THE PUMP COVER WAS REMOVED AND EVIDENCE OF INTERNAL MOISTURE WAS FOUND. 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

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED HE WAS IN THE POOL APPROXIMATELY 30 MINUTES PRIOR TO CALLING AND NOW THE PUMP LOST POWER. 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
    324401 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR