BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132383 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07164
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 08/08/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO DAMAGE OBSERVED DURING A VISUAL INSPECTION OF THE PUMP. DURING TESTING, THE PUMP POWERED ON WITH VIBRATORY AND AUDIBLE SOUNDS. THE DISPLAY SCREEN WAS DISCOLORED. A TEST SCREEN WAS INSTALLED AND DISPLAYED NORMALLY. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS NOT WORKING PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235588 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR