BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842617 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13842
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED MULTIPLE LOSS OF PRIME WARNINGS WITH BOTH ZERO AND NON ZERO LOW FORCE. THE PUMP WAS EXERCISED FOR 24 HOURS ON A ONE UNIT BASAL RATE WITH NO LOSS OF PRIMES DUPLICATED. THE FORCE CALIBRATION TEST FAILED. THERE WAS MOISTURE CONTAMINATION FOUND IN FORCE SENSOR HOUSING AND FORCE SENSOR SHIM. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR PINS AND IN THE PUMP. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE CALIBRATION TEST FAILED INVESTIGATION. THERE WAS CONTAMINATION FOUND ON THE FORCE SENSOR PINS AND IN THE PUMP. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012.

    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 22 YR