BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3042236 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03826
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DIM/FADED AND DISCOLORED DISPLAY SCREEN. UNRELATED TO THE DISPLAY ISSUE, THE BATTERY CAP WAS FOUND TO HAVE DAMAGED THREADS AND A CRACKED BATTERY COMPARTMENT WAS OBSERVED. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT AND THE PUMP FAILED THE LEAK TEST. THE BLACK BOX HISTORY WAS REVIEWED AND SHOWED MULTIPLE OCCURRENCES OF THE TIME AND DATE RESETTING. THE PUMP COVER WAS REMOVED AND A LEAK IN THE INTERNAL BATTERY WAS FOUND. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/FADED AND DISCOLORED DISPLAY SCREEN. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146691 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR