BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5694423 · Received June 2, 2016

    Report

    Report Number
    2531779-2016-10908
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Report Date
    May 11, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/06/2016 WITH THE FOLLOWING FINDINGS: THE BB SHOWS A LOSS OF PRIME EVENT ON (B)(6) 2016 18:43; DELIVERIES NEVER RESUMED. PUMP POWERS ON WITH NO ISSUES. PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED 2.0U AND TDD SHOWED 48.0U. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. NO DELIVERY DEFECTS FOUND DURING DELIVERY ACCURACY TESTING. PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. NO DELIVERY INTERRUPTIONS OR EAW¿S OCCURRED DURING TESTING. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. 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) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY SETTINGS ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 464MG/DL WITH NAUSEA. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND IT WAS NOTED THAT THE BASAL HISTORY DOES NOT MATCH ACTIVE BASAL PROGRAM. THIS REPORT IS BEING MADE DUE TO THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348626 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR