BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3032802 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03473
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DIM/FADED DISPLAY SCREEN. DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED EVIDENCE OF A VOLTAGE DROP ON (B)(6) 2013. UNRELATED TO THE COMPLAINT, A CRACKED BATTERY COMPARTMENT WAS OBSERVED. NO POWER LOSS WAS OBSERVED AND ALL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. EXCESSIVE BATTERY USAGE AND VOLTAGE DROP COULD NOT BE DUPLICATED DURING TESTING. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/FADED 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
    137015 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR