BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3875117 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17149
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/18/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2014 WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE PUMP SHOWED NO DAMAGE TO THE KEYPAD COVER. DURING TESTING, ALL THE KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND NO DAMAGE OR CONTAMINATION WAS FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (BUTTON/KEYPAD ISSUE) ISSUE. IT WAS ALLEGED THAT DURING PRIMING, THE PUMP DID NOT SOUND NORMAL AND THE BUTTON WAS RELEASED. DURING THE NEXT ATTEMPT TO PRIME, THE PUMP WOULD NOT STOP PRIMING DESPITE THE OK BUTTON BEING RELEASED. MULTIPLE BUTTONS WERE THEN PRESSED AND THE PUMP WAS THEN ABLE TO BE STOPPED FROM PRIMING INSULIN. 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
    351978 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR