BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223663 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10444
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/10/2013 DEVICE EVALUATION:THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/20/2013 WITH THE FOLLOWING FINDINGS:INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT AND VISIBLE CORROSION IN THE COMPARTMENT. THE PUMP DID NOT POWER ON TO THE VERIFY SCREEN AND THE DISPLAY SCREEN REMAINED BLANK. THE PUMP HAD NO AUDIBLE OR VIBRATORY SOUNDS. ADDITIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO INABILITY TO POWER ON THE PUMP. A BATTERY COMPARTMENT LEAK FOUND DURING LEAK TEST. THE PUMP COVER WAS REMOVED AND INTERNAL MOISTURE WAS OBSERVED IN THE PUMP. 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 THE PATIENT REPLACED THE BATTERY AND ATTEMPTED TO REBOOT HER PUMP BUT THE PUMP DID NOT POWER ON WITH BATTERY CHANGE. 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
    323641 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR