BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3970479 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21932
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/06/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. DUE TO INTERNAL MOISTURE DAMAGE, THE PUMP INTERMITTENTLY POWERED ON WITH NO VIBRATORY FEATURES AND AN UNRESPONSIVE KEYPAD. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE BATTERY CAP WAS UNABLE TO FULLY SECURE ONTO THE PUMP, AND THE BATTERY CAP THREADS WERE OBSERVED TO BE DAMAGED. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON THE INTERIOR OF THE BATTERY CAP. THE LEAK TEST FAILED DUE TO A BATTERY COMPARTMENT LEAK. THE PUMP WAS OPENED AND MOISTURE WAS OBSERVED ON INTERNAL COMPONENTS OF THE PUMP. THE INVESTIGATION FOR THE ¿BATTERY LIFE¿ COMPLAINT COULD NOT BE COMPLETED DUE TO THE INABILITY TO MEASURE THE ELECTRICAL CURRENT DRAWS AND REVIEW THE BLACK BOX DATA.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. 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
    447477 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR