BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3901616 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18604
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: THE DATES IN THE TOTAL DOSE HISTORY WERE INCONSISTENT AND THERE WAS NO DATA IN THE BLACK BOX FROM THE INCONSISTENT DATES DUE TO CONTINUED PUMP USE. THE DAILY INSULIN DELIVERY TOTALS APPEARED INCONSISTENT DUE TO DATE CHANGES. UNRELATED TO THE INITIAL COMPLAINT, THE KEYPAD BUTTONS WERE UNRESPONSIVE TO TESTING. THE KEYPAD NEEDED TO BE REPAIRED TO ALLOW FURTHER TESTING. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AND THE THREADS ON THE BATTERY CAP WERE OBSERVED TO BE STRIPPED. A TEST CAP WAS USED FOR ALL INVESTIGATION STEPS. 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.

    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 HISTORY/SETTINGS (INACCURATE DELIVERY) ISSUE. 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 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
    379890 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR