BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243047 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11750
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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. 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 PATIENT CONTACTED ANIMAS ALLEGING THAT HER BLOOD GLUCOSE (BG) HAS BEEN ELEVATED AND SHE DID NOT THINK THE PUMP WAS DELIVERING INSULIN. THE PATIENT STATED HER BG HAD BEEN ELEVATED FOR THE PAST 24 HOURS. THE PATIENT STATED SHE HAD GONE TO THE ER EARLIER WITH NAUSEA, VOMITING, AND KETONES. THE PATIENT WAS REPORTEDLY GIVEN FLUIDS. THE PATIENT STATED SHE CAN GET HER BG DOWN TO 300MG/DL BUT THEN IT WILL ELEVATE AGAIN. THE PATIENT REPORTED HER BG AT THE TIME OF THE CALL TO BE 430MG/DL. THE PATIENT DID NOT REPORT ANY SIGNS OR SYMPTOMS WITH THE MOST RECENT BG. THE PATIENT WAS WEARING THE PUMP AT THE TIME OF THE CALL TO ANIMAS BUT WAS UNABLE TO TROUBLESHOOT. THE PATIENT STATED THAT SHE HAD CHANGED HER SITE THREE TIMES AND THERE WERE TO SITE OR SET ISSUES. THE PATIENT REPORTEDLY CHANGES THE SET EVERY THREE DAYS AND STAYS AWAY FROM AREAS WITH SCAR TISSUE. THE PATIENT STATED SHE KEEPS INSULIN REFRIGERATED UNTIL SHE OPENS THE VIAL, AND THEN SHE STORES IT AT ROOM TEMPERATURE. CUSTOMER TECHNICAL SUPPORT MADE ATTEMPTS TO CONTACT THE PATIENT TO COMPLETE TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION AND BASED ON THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343208 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R