BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3913910 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18891
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/23/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION DID NOT REVEAL ANY CRACKS ON THE DISPLAY SCREEN; THE INITIAL COMPLAINT WAS NOT DUPLICATED. SCRATCHES WERE FOUND ON THE DISPLAY FILM, BUT ONLY AT THE SEVERITY OF A COSMETIC ISSUE. UNRELATED TO THIS COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. REPORTEDLY, THE DISPLAY WAS CRACKED. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP AND THE SCREENS CANNOT BE READ/MANEUVER SAFELY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389409 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR