BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2954988 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01675
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DATE OF SUBMISSION 04/03/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON APPROPRIATELY WITH FUNCTIONAL VIBRATORY FEATURES. AUDIBLE SOUNDS WERE NOT PRESENT ON START UP. ALL AUDIO SETTINGS WERE CONFIRMED TO BE SET TO ¿HIGH¿. THE PUMP COVER WAS REMOVED AND A COLD SOLDER CONNECTION WAS OBSERVED. THE ABSENCE OF AUDIBLE SOUND WAS ATTRIBUTED TO THE SOLDER ISSUE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THERE WAS NO AUDIO TONE AND VIBRATION WHEN REPLACING THE BATTER RECENTLY. THE PATIENT CONFIRMED ALL SOUND SETTINGS AS BEING ON. THE PATIENT STATED THAT THEY ARE HARD OF HEARING AND HAS SETTINGS ON HIGH. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE DUAL ALARM FAILURE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58934 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR