BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3153098 · Received June 8, 2013

    Report

    Report Number
    2531779-2013-07889
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/27/2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE PUMP¿S VIBRATORY AND AUDIBLE TONE FEATURES WAS FOUND TO BE WORKING WHEN THE PUMP WAS POWERED ON. ALL USER SOUND SETTINGS WERE CONFIRMED TO BE SET TO ¿VIBRATE.¿ A10 UNIT BOLUS WAS SUCCESSFULLY PERFORMED ON THE PUMP; THE PUMP EMITTED THE APPROPRIATE VIBRATORY TONE AND DISPLAYED THE CORRECT MESSAGE ON THE SCREEN. A ¿LOW BATTERY¿ WARNING WAS INDUCED DURING TESTING; THE PUMP EMITTED THE APPROPRIATE VIBRATION WARNING AND DISPLAYED THE CORRECT MESSAGE ON THE SCREEN. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING AN AUDIO TONE/VIBRATION (NO VIBRATION) ISSUE. IT WAS REPORTED THAT THE PUMP HAD A LOSS OF VIBRATORY SIGNALS. 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
    256008 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR