BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3000386 · Received March 12, 2013

    Report

    Report Number
    2531779-2013-02638
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION PROCESS. PUMP POWERS ON WITH AUDIBLE AND VIBRATORY SOUNDS. THE BLACK BOX AND ALARM HISTORY SHOW NO ERRORS OR ALARMS RELATED TO THE COMPLAINT. A NORMAL 10U BOLUS AND A 10U AUDIO BOLUS WERE PROGRAMMED AND THE PUMP DISPLAYED THE CORRECT BOLUS MESSAGE ON THE SCREEN. BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY WITH NO ISSUES. A EZCARB BOLUS WAS ALSO CORRECTLY CALCULATED AND PERFORMED WHILE SHOWING THE CORRECT MESSAGE ON THE DISPLAY SCREEN.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT WHEN THE PATIENT BOLUSES THE CORRECT SETTINGS DOES NOT COME ON THE PUMP. THE PATIENT IS AT SCHOOL WITH THE PUMP SO UNABLE TO TROUBLESHOOT AT THIS TIME. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103743 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR