BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2020558 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00508
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    December 30, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER SON (THE PATIENT) ALLEGING THAT THE PUMP FELT WARM OR HOT TO TOUCH. THE REPORTER DENIED THAT THE PATIENT WAS BURNED BECAUSE OF THE ALLEGED ISSUE. SHE ALSO DENIED THAT ANY MEDICAL ATTENTION WAS NEEDED. THE REPORTED DENIED THAT THE BATTERY COMPARTMENT WAS CRACKED OR HAD CORROSION. SHE CONFIRMED THAT THE BATTERY CAP WAS INTACT AND THE YELLOW O-RING WAS NOT VISIBLE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP FELT HOT TO TOUCH. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1