BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130977 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27950
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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 08/19/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/26/2016 WITH THE FOLLOWING FINDINGS: THE PUMP'S BLACK BOX SHOWED THAT THE DATA FROM THE DATE OF THE ISSUE HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE CURRENT BLACK BOX DATA SHOWED NO EVIDENCE OF SHORT BATTERY LIFE. THE PUMP'S CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE ALLEGED ISSUE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A BATTERY LIFE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609405 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR