BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2161442 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04929
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    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

    CORRECTION NUMBER: 2531779-03/24/2010/003-R. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2011. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT 'LOSS OF PRIME' WARNINGS HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. CONTAMINATION WAS FOUND ON THE FORCE SENSOR ASSEMBLY, AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. 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 MULTIPLE 'LOSS OF PRIME' WARNINGS. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THIS REPORT IS BEING MADE BASED ON RESULTS OF INVESTIGATION.

    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 15