BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192958 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09118
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 29, 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

    FOLLOW UP #1 SUBMITTED: 09/10/2013- 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. DEVICE EVALUATION: REVIEW OF THE ALARM HISTORY DID NOT REVEAL ANY RECORD OF ERRORS OR ALARMS RELATED TO THE COMPLAINT. THE PUMP POWERED ON NORMALLY. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY AND WAS CLEARLY LEGIBLE. ON TESTING, ALL THE KEYPAD BUTTONS HAD PROPER RESPONSE WITHOUT STICKING OR HYPERSENSITIVITY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY ISSUES. TEST BOLUSES WERE SUCCESSFULLY PERFORMED WITHOUT DELAY IN RESPONSE AND WERE ACCURATELY RECORDED IN THE PUMP HISTORY. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE BOLUS DELIVERY WAS DELAYED IN RESPONSE BY A FEW MINUTES. THE REPORTER DENIED THAT THIS WAS A KEYPAD BUTTON ISSUE. 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
    294468 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR