BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3133116 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07101
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    DEVICE EVALUATION - (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING RESULTS: THE COMPLAINT WAS NOT DUPLICATED DURING TESTING. THE BATTERY COMPARTMENT AND CAP ARE INTACT AND ABLE TO FIT SECURELY. THE BATTERY CAP IS ABLE TO MAINTAIN ELECTRICAL CONNECTION. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. PUMP WAS PRIMED AND EXERCISED CORRECTLY; NO ALARMS OR OVERHEATING WAS DUPLICATED DURING THE COURSE OF TESTING. CURRENT DRAWINGS WERE MEASURED USING A POWER SUPPLY, AND THEY WERE FOUND WITHIN THE NOMINAL VALUES. THE COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT. BLACK BOX REVIEW SHOWS A ¿177¿ WARNING OCCURRED ON (B)(6) 2013 AS A RESULT OF A STUCK VP FOR 3H POST A CANULA-BOLUS. NO OTHER ACTIVITY OUTSIDE OF NORMAL USE IS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMPERATURE ISSUE) ISSUE. IT WAS REPORTED THAT THE BATTERY FELT HOT TO THE TOUCH WHEN IT WAS REMOVED FROM THE PUMP. 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
    234336 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR