BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2200908 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05781
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR AND LEAD SCREW. DURING TESTING, THE LOAD STEP STOPPED SHORT AT 197 UNITS; THIS ISSUE IS NOT LIKELY TO CAUSE AN INJURY BECAUSE PATIENTS ARE INSTRUCTED TO PRIME UNTIL DROPS ARE SEEN COMING FROM THE END OF THE TUBING. UNRELATED TO THE COMPLAINT, BATTERY CAP WAS FOUND TO BE DAMAGED AND THERE WAS EVIDENCE OF MOISTURE AND CORROSION IN THE PUMP. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. 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

    EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY AND CONTAMINATION ON THE FORCE SENSOR. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR