BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3203104 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09554
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/10/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2013 WITH THE FOLLOWING FINDINGS:THERE WERE NO ALARMS RELATED TO COMPLAINT OBSERVED IN BLACK BOX. NO "POWER ON RESETS" OR "REBOOT CONDITIONS" OBSERVED IN BLACK BOX. THE BATTERY COMPARTMENT INTACT, NO CRACKS. NO EVIDENCE OF MOISTURE INSIDE BATTERY COMPARTMENT. BATTERY CAP IS ABLE TO FULLY TIGHTEN. A POWER LOSS WAS NOT OBSERVED. THE BATTERY CAP HEIGHT AND WIDTH MEASURES WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS. NO POWER LOSS OR BATTERY RELATED WARNINGS WERE OBSERVED. THE PUMP CASE WAS REMOVED, NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS IDENTIFIED INSIDE PUMP. INSPECTED BATTERY TERMINAL CONTACTS, NO EVIDENCE OF INTERMITTENT CONTACT. A "INTERMITTENT POWER" ISSUE WAS NOT OBSERVED HOWEVER AN INTERMITTENT CONNECTION AT THE DISPLAY FLEX CONNECTOR CAUSING A BLANK DISPLAY WAS OBSERVED. A TEST DISPLAY WAS USED AND THE INTERMITTENT CONNECTION CAUSING THE BLANK DISPLAY WAS DUPLICATED.

    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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (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
    302219 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR