BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223640 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10414
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 09/25/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2013 WITH THE FOLLOWING RESULTS: THE BLACK BOX RECORDED MULTIPLE POWER ON RESETS. VISIBLE MOISTURE IN DISPLAY. POWERED UP PUMP. THE DISPLAY WAS BARELY READABLE, DUE TO MOISTURE ON LENS, LINES IN DISPLAY, AND FADING DISPLAY. THE DISPLAY FINALLY FADED TO A BLANK SCREEN. UNABLE TO COMPLETE REWIND OR 24 HR TEST DUE TO BLANK SCREEN. LEAK TEST FAILED DUE TO CRACKED PUMP CASE. CASE CRACKED IN THE UPPER RIGHT CORNER BETWEEN THE LENS AND CASE SEAL. NO CORROSION OR CRACKS IN BATTERY COMPARTMENT, OR BATTERY CAP.OPENED PUMP AND REMOVED FROM CASE. MOISTURE AND CORROSION WAS PRESENT ON ALL SURFACES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THE PATIENT WENT SWIMMING AND ALLEGED THERE IS NO POWER TO THE PUMP. THE REPORTER STATED THAT THERE WAS MOISTURE BEHIND THE SCREEN. 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
    324600 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR