BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4242009 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32066
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF PEELING OR DAMAGE TO THE KEYPAD COVER. THE OKAY BUTTON WAS OVER RESPONSIVE. HOWEVER, THE CONTRAST, DOWN ARROW, AND UP ARROW BUTTONS WERE NORMALLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND THERE WAS NO EVIDENCE OF CONTAMINATION ON THE KEY CONTACTS. THE OKAY BUTTON WAS OBSERVED TO HAVE AN INVERTED KEY CONTACT. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED IN THREE PLACES: NEAR THE TOP, BELOW THE BUMPER PAD, AND BETWEEN THE BUMPER PAD AND THE TOP. THE DISPLAY WAS FOUND TO BE DIM AND PINK. A CRACK IN THE CASE NEAR THE UPPER RIGHT CORNER OF THE DISPLAY WAS OBSERVED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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 THAT ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE. 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
    721765 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR