BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201865 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09537
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/12/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/23/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED TOTAL DAILY DOSES ADDED UP CORRECTLY TO REFLECT THE USER¿S PROGRAMMED BASAL RATES. DURING TESTING, AN EZ CARB BOLUS WAS REPRODUCED FOR THE INVESTIGATION USING INFORMATION FROM THE COMPLAINT AND THE USER¿S SETTINGS; ACTUAL BG: 160MG/DL, CARB: 30G, I:C: 1U:20G, BG TARGET:145MG/DL, IFS: 100MG/DL. THE PUMP CORRECTLY CALCULATED A 2.05 UNIT BOLUS. THE PUMP WAS ABLE TO SUCCESSFULLY PERFORM A 10 UNIT AUDIO BOLUS AND A 10 UNIT NORMAL BOLUS; BOTH WERE ACCURATELY RECORDED IN THE PUMP¿S HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. NO ERRORS, ALARMS, OR WARNINGS OCCURRED DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP DID NOT CALCULATE THE CORRECT BOLUS ON ONE OCCASION. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302553 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR