BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4043376 · Received August 27, 2014

    Report

    Report Number
    2531779-2014-24629
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/31/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS A MANUAL DATE CHANGE FROM (B)(6) 2014 21:26 TO (B)(6) 2014 21:28 AND FROM (B)(6) 2014 21:52 TO (B)(6) 2014 21:53. THE BASAL TOTAL DAILY DOSE (TDD) HISTORY APPEARS TO BE INACCURATE DUE TO THE MANUAL DATE/TIME CHANGE. THE PUMP WAS EXERCISED FOR 24HRS ON A 1.0U/HR BASAL RATE; AT CONCLUSION OF TEST THE TDD BASAL HISTORY CORRECTLY SHOWED 24.0U. NO ALARMS RELATED TO COMPLAINT IN ALARM HISTORY. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. UNABLE TO DUPLICATE COMPLIANT. THE DISPLAY SCREEN HAS PINKISH CONTRAST. BATTERY CAP WAS NOT RETURNED. NEW TEST BATTERY CAP AND RETURNED CARTRIDGE CAP USED TO COMPLETE TESTING. THE PUMP HAS AUDIBLE BUT NO VIBRATION. REMOVED PUMP COVER; DIRECT POWER WAS APPLIED TO THE VIBRATION MOTOR AND MOTOR WAS STILL UNRESPONSIVE. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522070 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR