BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3203358 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09562
    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
    OH, US
    Reporter Occupation
    OTHER

    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 DATE OF SUBMISSION 09/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED NO ERRORS OR ALARMS RELATED TO THE COMPLAINT; ONLY TYPICAL USAGE WAS OBSERVED. THE TOTAL DAILY INSULIN DELIVERY DOSES ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATES. 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. 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.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT REPORTED IN ASSOCIATION WITH THIS COMPLAINT. ON (B)(6) 2013, IT WAS REPORTED THAT THE PUMP "WAS HAVING INSULIN DELIVERY PROBLEMS." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE CONTACT. MULTIPLE ATTEMPTS TO REACH THE REPORTER HAVE BEEN UNSUCCESSFUL. THIS COMPLAINT IS BEING REPORTED BASED ON THE CONCLUSION THAT A NON-SPECIFIC INSULIN DELIVERY ISSUE HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301104 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR