BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113775 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06455
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED NO EVIDENCE OF REBOOTS. DURING EVALUATION OF THE PUMP, THE BATTERY COMPARTMENT AND BATTERY CAP WERE EXAMINED AND NO DAMAGE WAS OBSERVED. THE BATTERY CAP CONTACT HEIGHT AND WIDTH WERE BOTH OBSERVED TO BE WITHIN SPECIFICATIONS AND THE CAP WAS ABLE TO FULLY ATTACH TO THE PUMP. THE PUMP WAS POWERED ON AND EXERCISED FOR 24 HOURS WITH NO POWER ISSUES. DURING TESTING, 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND IDLE, SLEEP, REWIND, AND LOAD CURRENTS ALL ARE WITHIN SPECIFICATION. REMOVAL OF THE PUMP COVER SHOWED NO EVIDENCE OF INTERNAL MOISTURE AND NO LOOSE COMPONENTS OR INTERMITTENT CONNECTIONS WERE IDENTIFIED INSIDE PUMP. UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS MISSING.

    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. 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 CONTACTED ANIMAS ALLEGING THAT THE PUMP HAD POWERED OFF DURING THE NIGHT AND THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) OF 331MG/DL WITH KETONES. THE PUMP WAS SUCCESSFULLY POWERED BACK ON AND THE PATIENT'S BG WAS TREATED WITH A BOLUS. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING AT THE TIME OF THE INITIAL CALL. CUSTOMER TECHNICAL SUPPORT HAD ATTEMPTED TO REACH THE REPORTER FOR TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO A POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214164 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening