BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3933766 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20003
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 11, 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/04/2015-PRODUCT ANALYSIS:THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/18/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT WAS UNABLE TO BE DUPLICATED WITH INVESTIGATION. THE KEYPAD WAS FOUND TO BE INTACT; NO DAMAGE WAS OBSERVED. EVALUATION REVEALED ALL KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THERE WAS NO EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE KEY CONTACTS. MOISTURE WAS OBSERVED ON THE PUMP¿S PRINTED CIRCUIT BOARD AND KEYPAD CONNECTOR. UNRELATED TO THE COMPLAINT, A PUMP CASE CRACK WAS DISCOVERED. A BROKEN ACCESSORY CLIP WAS FOUND IN THE U-GROVE ACCESSORY ATTACHMENT FEATURE OF THE PUMP CASE. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE. ALLEGEDLY, AN UNDER DELIVERY OF INSULIN OCCURRED DUE TO THIS ISSUE. 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
    412394 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR