BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3121808 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06788
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN 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 11/17/2015, DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/30/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX STARTED ON (B)(6) 2015. THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED AND THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. THE PUMP WAS EXERCISED FOR A 24HR DURATION PERIOD WITH NO SELF-SUSPENDING DURING THAT TIME PERIOD. THERE WAS NO HYPERSENSITIVITY TO THE BUTTONS ON THE KEYPAD. THE PUMP WAS ABLE TO BE MANUALLY SUSPENDED AND MANUALLY RESUMED WITH NO ISSUES. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS SUSPENDED UNINTENTIONALLY DURING ROUTINE PUMP FUNCTION RESULTING IN THE PATIENT EXPERIENCING BLOOD GLUCOSE LEVELS AS HIGH AS 539 MG/DL. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO UNINTENTIONAL SUSPENSION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223528 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening