BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2093500 · Received May 18, 2011

    Report

    Report Number
    2531779-2011-03525
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/06/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON TO THE VERIFY SCREEN WITH FUNCTIONAL VIBRATORY ALARMS; THERE WERE NO AUDIBLE TONES OBSERVED DURING TESTING. INVESTIGATION REVEALED A DAMAGED CONNECTION BETWEEN THE PIEZO DISK AND THE CONTACT PAD. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    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

    PATIENT REPORTS THAT PUMP'S SOUND IS NOT WORKING; NOTICED THIS ISSUE (B)(6). ALL TONES ARE SET TO HIGH. DURING TROUBLESHOOTING, VIBRATORY FUNCTION WAS REPORTEDLY NOT WORKING. THIS IS REPORTED DUE TO THE ALLEGATION THAT AUDIBLE AND VIBRATORY ALARM FUNCTIONS OF THE PUMP ARE NO LONGER WORKING CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR