BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130117 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27921
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 11/28/2014 ¿ DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO ACTIVITY RELATED TO THE COMPLAINT WAS RECORDED. DURING TESTING, A 10 UNIT BOLUS WAS CANCELLED AFTER 5 UNITS WERE DELIVERED. THE STATUS SCREEN DISPLAYED THAT THE INSULIN ON BOARD WAS 5 UNITS. THE INSULIN ON BOARD WAS FOUND TO BE CALCULATING CORRECTLY. THE COMPLAINT THAT THE TOTAL AMOUNT OF A CANCELLED BOLUS WAS ON BOARD WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP INSULIN ON BOARD (IOB) FEATURE DISPLAYED THAT THE TOTAL AMOUNT OF A CANCELLED BOLUS WAS ON BOARD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A HISTORY/SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607822 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR