BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2904021 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00423
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 10/26/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/08/2015 WITH THE FOLLOWING FINDINGS:THERE WAS NO BLACK BOX DATA FROM THE TIME OF THE EVENT DUE TO CONTINUED USE OF THE PUMP. THE CURRENT BLACK BOX DATA SHOWED EVIDENCE OF TYPICAL PATIENT USAGE. DURING TESTING, THE PUMP POWERED ON AND WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES, ALARMS, OR OTHER ISSUES OCCURRING.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(4) 2012 REPORTING THAT THE PUMP STOPPED WORKING. THE REPORTER INDICATED THAT THE PATIENT APPARENTLY STOPPED EATING SINCE THE PUMP STOPPED. THERE WERE NO REPORTED BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11936 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR