BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113423 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06439
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/08/2013 WITH THE FOLLOWING RESULTS: BLACK BOX SHOWS NO VALID OCCURRENCES OF A TIME AND DATE RESET TO THE DEFAULT SETTING. TIME AND DATE WAS ACCURATELY SET AT START OF INVESTIGATION. THE BENCH TOP ANALYSIS VERIFIED WHEN THE BATTERY WAS REINSERTED AFTER 6HRS WITHOUT POWER,TO ENSURE THE INTERNAL BATTERY WAS FULLY CHARGED, THE PUMP WAS EXERCISED FOR 24HRS ON A 1.0U/HR BASAL PROGRAM. TIME AND DATE WAS CORRECTLY MAINTAINED DURING 24HR TEST. AFTER 24HRS THE BATTERY WAS REMOVED FOR 6HRS, THE TIME AND DATE RESET TO FACTORY DEFAULT SETTINGS. A VISUAL INSPECTION CONFIRMED THE INTERNAL BATTERY WAS LEAKING. UNRELATED, THE DISPLAY SCREEN HAS A PINKISH CONTRAST. REMOVED THE PUMP COVER AND REPLACED PINK DISPLAY WITH NEW TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST AND NO SYMPTOMS OF DISCOLORATION. 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PUMP TIME AND DATE WAS RESETTING TO DEFAULT TIME AND DATE OWN ITS OWN WITHOUT BATTERY CHANGES OR PUMP REBOOTING. THE REPORTER STATED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE LEVELS AS HIGH AS 33 MMOL/L WITH NO ASSOCIATED SYMPTOMS RELATED TO THE ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO AN ALLEGED TIME AND DATE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214175 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening