BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3850137 · Received June 4, 2014

    Report

    Report Number
    2531779-2014-15846
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/16/2014, DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP CASING WAS INTACT WITH NO DAMAGES OBSERVED. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. ALL THE BUTTONS FUNCTIONED PROPERLY. THE INVESTIGATION WAS UNABLE TO DUPLICATE THE REPORTED CASING ISSUES. UNRELATED TO THE REPORTED CASING ISSUE, THE TOP RIGHT PART OF THE DISPLAY LENS WAS FOUND TO HAVE CRACKED AND IT WAS OBSERVED THAT THE VERIFY SCREEN WAS 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 CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. REPORTEDLY, THE PUMP CASING AROUND THE DISPLAY WAS DAMAGED. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY CAP AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. 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
    326426 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR