BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4101017 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26789
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND NO COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA SHOWED THAT THE LAST BOLUS AND LAST BASAL WERE DELIVERED TWO AND THREE DAYS AFTER THE COMPLAINT DATE RESPECTIVELY. THE TOTAL DAILY DELIVERIES ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL SETTINGS. THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS. BOLUS EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE INVESTIGATION WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED INACCURATE DELIVERY ISSUE.

    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. REVIEW OF BOLUS HISTORY SHOWED THAT BOLUS TOTALS ADD UP CORRECTLY AND ALL BOLUSES ARE RECORDED AS PROGRAMMED. 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
    584372 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR