BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3782592 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-12063
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 05/23/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/19/2014 WITH THE FOLLOWING FINDINGS: CS 078-0008 VERIFIED IN BLACK BOX AND HISTORY. BATTERY COMPARTMENT CRACKED FROM CASE SEAL TO GRIP. RECEIVED CS 078-0008 DURING INVESTIGATION. OPENED PUMP AND REMOVED FROM CASE. CORROSION ON MOTOR FLEX CABLE CONNECTOR.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2014 REPORTING A CALL SERVICE ALARM ISSUE. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE CALL SERVICE ALARM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260867 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR