BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181523 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05363
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR MULTIPLE LOSS OF PRIME WARNINGS. EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON 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 32 YR