BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4133832 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28087
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/18/2014 WITH THE FOLLOWING FINDINGS:THE INITIAL COMPLAINT ABOUT THE KEYPAD COULD NOT BE DUPLICATED. THE KEYPAD WAS INTACT WITH NO EVIDENCE OF PEELING OR DAMAGE. ALL OF THE KEYPAD BUTTONS WERE RESPONSIVE. THERE WAS NO EVIDENCE OF CONTAMINATION ON THE KEY CONTACTS. UNRELATED TO THE INITIAL ALLEGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS CRACKED BELOW THE BUMPER PAD. THE AUDIO BOLUS BUTTON WAS DETACHED FROM THE PUMP AND MISSING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE UP, DOWN, AND OK KEYPAD BUTTONS WERE UNDER-RESPONSIVE. 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
    611189 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR