BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2872880 · Received December 13, 2012

    Report

    Report Number
    2531779-2012-14542
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED THAT THE PUMP DID NOT DETECT THE CARTRIDGE. INVESTIGATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THERE WAS EVIDENCE OF MOISTURE AND CONTAMINATION FOUND ON THE FORCE SENSOR HOUSING AND SHIM.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE PUMP DID NOT DETECT THE CARTRIDGE. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THERE WAS EVIDENCE OF MOISTURE AND CONTAMINATION FOUND ON THE FORCE SENSOR HOUSING AND SHIM. 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 32 YR