BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3852493 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15966
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED A REBOOT ON 06/03/2014. A VISUAL INSPECTION SHOWED EVIDENCE OF MOISTURE CONTAMINATION ON THE UNDERSIDE OF THE BATTERY CAP. THE BATTERY COMPARTMENT WAS INTACT. THE PUMP INTERMITTENTLY POWERED ON WITH THE RETURNED BATTERY CAP. A TEST CAP WAS USED; THE TEST CAP WAS ABLE TO FULLY TIGHTEN ON TO THE PUMP WITH NO POWER LOSS. THE PUMP WAS EXERCISED WITH THE TEST BATTERY CAP WITH NO REBOOTS, POWER LOSS, OR CALL SERVICE ALARMS. THE PUMP PASSED A LEAK TEST. THE PUMP COVER WAS OPENED AND NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) 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
    329141 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR