BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2801045 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12620
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 26, 2012
    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 WAS RETURNED AND WAS EVALUATED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED SEVERAL LOSS OF PRIME WARNINGS RECORDED IN THE BLACK BOX AS WELL AS SEVERAL TIME AND DATE RESETS. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP FOR INVESTIGATION HAD CORROSION ON THE SPRING. ON EXAMINATION, THERE WAS VISIBLE CORROSION IN THE BATTERY COMPARTMENT. ON TESTING, THE VIBRATOR MOTOR WAS NOT FUNCTIONAL. A REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED WITH NO LOSS OF PRIME. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIME. A FORCE SENSOR CALIBRATION TEST REVEALED THAT THE FORCE SENSOR WAS OUT OF SPECIFICATION. A LEAK TEST WAS PERFORMED AND REVEALED A LEAK AT THE DISPLAY LENS. THE PUMP COVER WAS REMOVED FOR INVESTIGATION AND REVEALED MOISTURE INSIDE THE PUMP. CORROSION WAS NOTED ON THE INTERNAL BATTERY, THE FORCE SENSOR, FORCE SENSOR PLATE, FORCE SENSOR INTERNAL MOTOR GEARS AND THE VIBRATOR MOTOR.

    Additional Manufacturer Narrative · 1

    RECALL # 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS CORROSION ON THE SPRING OF THE BATTERY CAP, INTERNAL BATTERY, FORCE SENSOR AND VIBRATOR MOTOR. REVIEW OF THE BLACK BOX REVEALED SEVERAL LOSS OF PRIME RECORDED. 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 ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR