BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3213068 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09959
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/12/2013 WITH THE FOLLOWING RESULTS: TESTING DID NOT CONFIRMED THE UNRESPONSIVE KEYPAD COMPLAINT. ALL KEYPAD BUTTONS ARE RESPONSIVE. REMOVED KEYPAD COVER TO CHECK THE CONDITION OF KEY CONTACTS, NO EVIDENCE OF CONTAMINATION WAS FOUND UNDER ANY KEY CONTACTS. UNRELATED TO COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS MISSING. UNABLE TO TEST THE AUDIO BOLUS BUTTON RESPONSIVE DUE TO THE AUDIO BOLUS BUTTON COVER WAS MISSING: HEAR SOUND BUT UNABLE TO OBTAIN AUDIBLE READING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE TO BUTTON PRESSES. 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
    314199 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR