BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233747 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11288
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/21/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON WITH AN AUDIBLE TONE AND VIBRATION ALARM. THE DISPLAY REMAINED BLANK DUE TO INTERNAL MOISTURE DAMAGE. DURING EVALUATION, A CRACK IN THE PUMP CASE WAS OBSERVED IN UPPER CORNER OF DISPLAY AREA. TESTING FOR THE POWER ISSUE COULD NOT BE COMPLETED DUE TO THE INTERNAL MOISTURE DAMAGE. THE PUMP CASE WAS REMOVED AND THERE WAS EVIDENCE OF MOISTURE DAMAGE ON INTERNAL COMPONENTS OF THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. IT WAS REPORTED THAT THE PUMP HAS LOST POWER AND IS NOT POWERING BACK ON. NO VISUAL ISSUES WERE FOUND ON THE PUMP. 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
    334343 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR