BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3150286 · Received June 6, 2013

    Report

    Report Number
    2531779-2013-07852
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THAT NO WARNINGS RELATED TO THE COMPLAINT OCCURRED; MULTIPLE PUMP REBOOTS WERE OBSERVED ON (B)(6) 2013. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO BE FULLY TIGHTENED. A POWER LOSS WAS NOT OBSERVED DURING TESTING. THE BATTERY CAP WIDTH AND HEIGHT WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR BATTERY RELATED WARNINGS OBSERVED. WHEN THE PUMP CASE WAS REMOVED, THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS IDENTIFIED INSIDE PUMP. THERE WAS NO EVIDENCE OF INTERMITTENT CONTACT WITH THE BATTERY TERMINAL CONTACTS. THE ISSUE OF NO POWER WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THEY ARE HAVING PROBLEMS WITH THE PUMP. THE REPORTER STATED THAT THEY CHANGED BATTERY YESTERDAY AND PUMP JUST DIED WITHOUT LOW BATTERY ALARM. THE ALARM HISTORY INDICATES BATTERY CHANGES OCCURRING FREQUENTLY. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250690 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR