BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3103072 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06111
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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: THE KEYPAD WAS FOUND TO BE INTACT. THE PUMP SUCCESSFULLY POWERED ON TO THE ¿VERIFY¿ SCREEN. THE KEYPAD BUTTONS WERE RESPONSIVE TO BUTTON PRESSES. THE PUMP WAS ABLE TO SUCCESSFULLY LOCK AND THEN UNLOCK AND EMIT THE APPROPRIATE LOCK ALARMS.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 AND ALLEGING A BUTTON/KEYPAD ISSUE. THE REPORTER STATED THE PUMP WOULD LOCK WITHOUT USER INTERVENTION AND COULD NOT USE THE KEYPAD BUTTONS TO UNLOCK THE PUMP. THE REPORTER ALSO ALLEGED THE PUMP WOULD CANCEL BOLUSES WITHOUT BUTTON PRESSES. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204119 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR