BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3032115 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03454
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PATIENT EXPERIENCED MULTIPLE SITE INFECTIONS FOR THE PAST 8 WEEKS. THE PATIENT REPORTEDLY WAS ON DIFFERENT ANTIBIOTICS FOR 6 WEEKS TO TREAT THE INFECTIONS. IT WAS ALSO NOTED THAT THE PATIENT HAD A STREP INFECTION. THE INFUSION SETS WERE REPORTEDLY CHANGED OUT MULTIPLE TIMES AND THE PATIENT WAS STILL HAVING ISSUES WITH SITE INFECTIONS. THE PATIENT'S SITE WAS REPORTEDLY RED, PUFFY AND INFLAMED. A LUMP WAS ALSO REPORTEDLY NOTICED WITH OCCASIONAL PUS. THE SAME BRAND TYPE OF INFUSION SET WAS REPORTEDLY USED. THE REPORTER STATED THAT PRIOR TO CHANGING OUT THE INFUSION SET, ALCOHOL WOULD BE USED TO STERILIZE THE AREA AND THE INFUSION SET WOULD BE TAPED DOWN WITH AND AN ADHESIVE PATCH OVER IT. IT WAS ALSO NOTED THAT RECENTLY THE PATIENT HAS BEEN USING DIFFERENT STERILIZATION WIPES TO CLEAN THE SITE AREA AND THEN NEOSPORIN WOULD BE APPLIED TO IT. THE HEALTH CARE PROVIDER (HCP) REPORTEDLY BELIEVED THERE MAY HAVE BEEN BACTERIA IN THE PUMP AND WANTED THE PUMP REPLACED. IT WAS NOTED THAT THE PATIENT DISCONTINUED INSULIN PUMP THERAPY. THERE NO DAMAGE NOTED WITH THE PUMP. IT IS UNLIKELY THAT THE PUMP CAUSED THE INFECTIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136635 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR