BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3251801 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12003
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/02/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. A TEST DISPLAY WAS USED FOR INVESTIGATION AND WAS FOUND TO FUNCTION APPROPRIATELY. UNRELATED TO THE DISPLAY ISSUE, TESTING REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND HAD STRIPPED THREADS. ADDITIONALLY, THE BATTERY CAP WAS FOUND TO HAVE STRIPPED THREADS DID NOT SECURE PROPERLY TO THE PUMP. THE BATTERY CAP CONTACT HEIGHT AND WIDTH WERE FOUND NOT TO BE WITHIN SPECIFICATIONS. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM, 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
    353088 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR