BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3971093 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21955
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/25/2014 WITH THE FOLLOWING FINDINGS: AN INEXPLICABLE REBOOT EVENT, WHICH IS INDICATIVE OF THE REPORTED EVENT, WAS OBSERVED IN THE BLACK BOX DATA. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA. NO EVIDENCE OF MOISTURE INGRESS WAS OBSERVED IN THE BATTERY COMPARTMENT OR CARTRIDGE COMPARTMENT. THE PUMP POWERED ON PROPERLY WITH THE RETURNED BATTERY CAP, WHICH WAS ABLE TO FULLY FASTEN TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER, OR CALL SERVICE ALARMS OBSERVED; THE REPORTED EVENT WAS NOT DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO THE BATTERY COMPARTMENT DAMAGE. THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF MOISTURE INGRESS WAS OBSERVED UNDER THE UP ARROW AND CONTRAST KEY CONTACTS. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF ADDITIONAL MOISTURE INGRESS WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT MOISTURE WAS EVIDENT IN THE CARTRIDGE COMPARTMENT. REPORTEDLY, THE PUMP WAS EXPERIENCING AN INTERMITTENT 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
    447910 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR