BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3973018 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22071
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/05/2015 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED MULTIPLE OCCLUSION ALARMS ASSOCIATED WITH HIGH FORCES. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS AND THE REWIND, LOAD, AND PRIME STEPS WERE COMPLETED SUCCESSFULLY WITH NO DUPLICATED CALL SERVICE ALARMS. THE FORCE SENSOR CALIBRATION MEASURED WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED, AND NO INTERNAL DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING AN OCCLUSION (FREQUENT/PERSISTENT) ISSUE. IT WAS REPORTED THAT THE PUMP REPEATEDLY EMITTED OCCLUSION ALARMS DESPITE MULTIPLE CARTRIDGE AND INFUSION SET CHANGES. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF AN OCCLUSION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450043 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR