BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4821580 · Received June 5, 2015

    Report

    Report Number
    2531779-2015-18739
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 23, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2015 WITH THE FOLLOWING FINDINGS. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. REVIEW OF THE BLACK BOX SHOWS A MANUAL TIME AND DATE CHANGE, FROM (B)(6) 2015 10:15 TO (B)(6) 2015 11:15. AND A MANUAL TIME AND DATE CHANGE FROM (B)(6) 2015 20:37 TO (B)(6) 2015 20:38. PUMP WAS EXERCISED FOR 24HRS WITH A 1.0U/HR BASAL PROGRAM. AT END OF TESTING THE BASAL HISTORY CORRECTLY SHOWED 1.0U AND TDD SHOWED 24.0U. NO ALARMS OCCURRED DURING TESTING. NO HYPERSENSITIVE KEYS OBSERVED ON THE KEYPAD. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED NEAR THE COVER.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE REPORTER CONTACTED ANIMA, ALLEGING AN INACCURATE DELIVERY ISSUE STARTING ON (B)(6) 2015. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THE BASAL DELIVERY TOTALS IN TDD DO NOT MATCH ACTIVE BASAL PROGRAM TOTAL , AND FOUND NO KNOWN CAUSE FOR VARIATION. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS THE DISCREPANCY IN BASAL DELIVERY TOTALS WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364414 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR