BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6170905 · Received December 13, 2016

    Report

    Report Number
    2531779-2016-33478
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 16, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 23-OCT-2018 WITH THE FOLLOWING FINDINGS: THE PUMP'S HISTORY FROM THE DATE OF THE EVENT HAVE BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE DEVICE. THE PUMP'S CURRENT DRAWS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT REQUIRING ASSISTANCE OF EMERGENCY PERSONNEL WHILE THE PATIENT WAS OFF THE PUMP DUE TO A SHORT BATTERY LIFE ISSUE. THE REPORTER DID NOT PROVIDE DETAILS OF THE ALLEGED ADVERSE EVENT BUT STATED THAT THE PATIENT HAD BEEN OFF THE PUMP FOR FIVE DAYS LEADING UP TO THE INCIDENT. THE REPORTER NOTED THAT THE PATIENT HAD DISCONTINUED THE PUMP DUE TO A RECURRING SHORT BATTERY LIFE ISSUE. DURING TROUBLESHOOTING, THE REPORTER CONFIRMED THAT THERE WERE LOW BATTERY WARNINGS IN THE PUMP HISTORIES AND THAT THE ISSUE HAD OCCURRED WITH MULTIPLE BATTERIES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT REQUIRING MEDICAL INTERVENTION WHILE THE PATIENT WAS OFF THE PUMP DUE TO A SHORT BATTERY LIFE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821586 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R