BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4157803 · Received October 9, 2014

    Report

    Report Number
    2531779-2014-28841
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/22/2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT. BLACK BOX SHOWS UNEXPLAINED POR ON (B)(6) 2014 08:00; DELIVERIES RESUMED (B)(6) 2014 08:09. PUMP WAS POWERED OFF ON (B)(6) 2014 22:37 TO CLEAR ALARM; PUMP WAS POWERED BACK ON AND DELIVERIES RESUMED (B)(6) 2014 22:46. BASAL HISTORY APPEARS TO BE INACCURATE DUE TO INCONSISTENT DATE/TIME. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. PUMP FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END OF TEST THE BASAL HISTORY CORRECTLY REFLECTED THE 2.0U/HR. BASAL RATE AND THE TDD HISTORY CORRECTLY EQUALED 48.0U. NO ALARMS OCCURRED DURING TESTING. 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. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THE BASAL HISTORY DOES NOT MATCH ACTIVE BASAL PROGRAM 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
    636566 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR