BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3150448 · Received June 6, 2013

    Report

    Report Number
    2531779-2013-07863
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BOLUS HISTORY SHOWED THAT AT 10:03 ON (B)(4) 2013 A 1.8 UNIT BOLUS WAS PROGRAMMED AND DELIVERED. THE PUMP WAS PROGRAMMED ON A 1.0 UNIT PER HOUR BASAL RATE AND EXERCISED FOR 24 HOURS; NO UNPROGRAMMED BOLUSES OCCURRED DURING TESTING. THE KEYPAD BUTTONS WERE INSPECTED AND NO HYPERSENSITIVITY WAS FOUND. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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

    ON (B)(6) 2013, THE REPORTER, THE PATIENT¿S MOTHER, CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) OF 574 MG/DL WITH THIRST AND TRACE KETONES . MOM HAS LOST CONFIDENCE IN THIS PUMP AND IS REQUESTING A REPLACEMENT. MOM REPORTS SITE, SET AND INSULIN ARE GOOD. MOM REPORTS BG THIS AM OF 220 MG/DL AT BREAKFAST, 5.25 UNIT BOLUS GIVEN AT 7:42 AM. THEN AT LUNCH BG WAS 574 MG/DL WITH MILD THIRST AND TRACE KETONES. MOM CHECKED BOLUS HISTORY, THE 5.25 UNIT BOLUS WAS COMPLETED. MOM ALLEGES AND UNPROGRAMMED BOLUS IN BOLUS HISTORY OF PUMP AND PATIENT HAVING AN UNEXPLAINED HIGH BG OF 574 MG/DL. MOM HAS REMOVED PATIENT FROM THE PUMP, GIVEN AN INJECTION OF INSULIN TO TREAT THE HIGH BG. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT A PATIENT ON PUMP THERAPY HAS EXPERIENCED HYPERGLYCEMIA POSSIBLY RELATED TO A BOLUS HISTORY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251569 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening