BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5577421 · Received April 14, 2016

    Report

    Report Number
    2531779-2016-07837
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Report Date
    March 30, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 05/27/2016 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/12/2016 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BB SHOWS THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2016 21:02, FOLLOWED BY A POR EVENT. THE PUMP WAS POWERED BACK ON AND DELIVERIES RESUMED AT (B)(6) 2016 21:30. THE PUMP WAS EXERCISED FOR 24HRS WITH A 1.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED 1.0U AND TDD SHOWED 24.0U. NO MISSING BASAL RATE WAS OBSERVED DURING TESTING. THE PUMP¿S BASAL RATES FOUND TO BE RECORDING PROPERLY. NO EAW¿S OR POR¿S OCCURRED DURING TESTING. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THE BATTERY COMPARTMENT IS CRACKED ABOVE AND BELOW THE BUMPER PAD. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING 1 HOUR OF BASAL RATES WERE MISSING FROM THE PUMP'S HISTORY. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235426 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR