BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3972740 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22054
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/11/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS NO EVIDENCE OF A BOLUS BEING DELIVERED OR CANCELLED ON THE EVENT DATE. AN EZCARB BOLUS WITH 55G OF CARBS WAS PROGRAMMED AND SUCCESSFULLY DELIVERED FROM THE METER TO THE PUMP. THE EZCARB BOLUS WAS SUCCESSFULLY RECORDED IN PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24HR WITH NO EAW¿S. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THE USER¿S BASAL RATES WERE CLEARED PRIOR TO DOWNLOADING. THERE WAS NO DEFECT FOUND. 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.

    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 (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS ALLEGED THAT THE PUMP¿S HISTORY DID NOT SHOW RECORD OF A BOLUS; ALTHOUGH IT WAS SHOWN IN THE METER. THE REPORTED INSISTED ON PUMP REPLACEMENT. 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
    450618 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR