BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050631 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-03978
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH FUNCTIONAL VIBRATORY AND AUDITORY FEATURES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. THE KEYPAD BUTTONS WERE TESTED AND NO HYPERSENSITIVITY WAS OBSERVED. A NORMAL 10UNIT BOLUS AND A 10UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. A ¿LOW BATTERY¿ WARNING WAS REPRODUCED DURING INVESTIGATION, AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERTS. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP DOES NOT ALWAYS EMIT A LOW BATTERY ALARM. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THIS REPORT IS BEING MADE DUE TO A HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149366 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR