BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210951 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09775
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2013 WITH THE FOLLOWING RESULTS: BLACK BOX SHOWS DATES FROM (B)(6) 2009 TO (B)(6) 2010. COMPLAINT WAS LOGGED ON (B)(6) 2013. THERE IS NO BLACK BOX DATA TO SUPPORT THAT TIMEFRAME. EXISTING BLACK BOX SHOWS MULTIPLE "POWER ON RESETS" ON (B)(6) 2009. RETURNED BATTERY CAP IS MISSING SPRING. A "NO POWER" CONDITION WAS DUPLICATED. ALL TESTING PERFORMED WITH A TEST BATTERY CAP. BATTERY COMPARTMENT INTACT, NO DAMAGE. NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. THE PUMP WAS EXERCISED WITH A TEST CAP FOR 24 HOURS. NO POWER LOSS OR BATTERY RELATED WARNINGS WERE OBSERVED. CURRENT DRAWS ARE WITHIN SPECIFICATIONS. PUMP CASE WAS REMOVED, NO EVIDENCE OF MOISTURE WAS OBSERVED INSIDE PUMP. INSPECTED BATTERY TERMINAL CONTACTS, NO EVIDENCE OF INTERMITTENT CONTACT. UNRELATED TO COMPLAINT, DISPLAY IS FADED, DISCOLORED AND DIFFICULT TO READ. REPLACED FADED DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (POWER ISSUE) ISSUE. THERE IS NO FURTHER INFORMATION REGARDING THE COMPLAINT AVAILABLE AT THIS TIME. 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
    309721 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1