BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2932790 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01281
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: DURING THE LOAD CARTRIDGE STEP, THE PUMP PUSHED OUT HALF OF THE CARTRIDGE PRIOR TO STOPPING. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND WITHIN THE FORCE SENSOR ASSEMBLY. UNRELATED TO THE COMPLAINT, EVIDENCE OF MOISTURE DAMAGE WAS FOUND ON THE PUMP MOTOR CIRCUIT; THE MOTOR WAS TESTED AND NO DEFECTS WERE FOUND. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. INVESTIGATION FOUND CONTAMINATION IN THE FORCE SENSOR ASSEMBLY. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38859 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR