BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3062737 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04392
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO VIBRATION OBSERVED WHEN POWERING UP THE PUMP; THE AUDIBLE TONE WAS FUNCTIONING APPROPRIATELY. THE PUMP COVER WAS REMOVED AND THE VIBRATION MOTOR WAS FOUND TO BE UNRESPONSIVE. POWER WAS APPLIED DIRECTLY TO THE VIBRATION MOTOR, AND IT WAS RESPONSIVE. THE VIBRATION MOTOR ALIGNMENTS PINS WERE OBSERVED TO BE MISALIGNED. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS FADED, DISCOLORED, AND DIFFICULT TO READ. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY AND THE CONTRAST RETURNED TO NORMAL WITH NO SIGNS OF FADING OR DISCOLORATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING AN AUDIO TONE/VIBRATION (NO VIBRATION) ISSUE. THE PATIENT REPORTED 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
    164367 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR