BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4230588 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31709
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2014 WITH THE FOLLOWING FINDINGS: INVESTIGATORS PERFORMED REWIND, LOAD AND PRIME STEPS WITH NO ALARMS. THE PUMP WAS OPENED AND INSPECTED THE LEAD SCREW AND MOTOR DRIVE ASSEMBLY AND THERE WAS NO DEFECT FOUND. THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TO THE GRIP. THERE WAS NO MOISTURE IN THE PUMP. THE DISPLAY WAS FADED AND PINK. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE DISPLAY WAS DIM AND PINK AND THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/03/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714587 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR