BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3831340 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14722
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 UNEXPLAINED REBOOTS. A VISUAL INSPECTION SHOWED THE BATTERY COMPARTMENT WAS INTACT AND THERE WAS NO DAMAGE TO THE RETURNED BATTERY CAP. THE BATTERY CAP CONTACT DIMENSIONS WERE WITHIN SPECIFICATIONS. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN ON TO THE PUMP WITH NO POWER LOSS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS. THE PUMP COVER WAS OPENED AND NO DAMAGE TO THE POWER CIRCUIT OR EVIDENCE OF INTERNAL MOISTURE WAS FOUND. THE COMPLAINT WAS CONFIRMED IN THE PUMP¿S HISTORY BUT NOT DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS 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 (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP INTERMITTENTLY LOST POWER. 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
    309629 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR