BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2963207 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01820
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/18/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP WAS ABLE TO BE PROGRAMMED WITHOUT DIFFICULTY. THE COMPLAINT COULD NOT BE DUPLICATED DURING TESTING.

    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 FOR AN UPDATE ON A SUPPLY ORDER AND DURING THE CALL STATED THE PUMP SHE RECEIVED "IS NOT WORKING." CUSTOMER TECHNICAL SUPPORT (CTS) ATTEMPTED TO OBTAIN CLARIFICATION, AND THE PATIENT STATED THAT "THE PUMP IS NOT ACCEPTING PROGRAMMING." THE PATIENT WOULD NOT PROVIDE ADDITIONAL DETAILS AND HUNG UP. CTS ATTEMPTED TO CONTACT TH "PATIENT FOR TROUBLESHOOTING, AND THE PATIENT THEN RETURNED CTS" CALLS. THE PATIENT STATED THAT SHE HAD PREVIOUSLY EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 400MG/DL BUT COULD NOT PROVIDE A CURRENT BG VALUE. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT REITERATED THAT THE REPLACEMENT PUMP SHE RECEIVED TODAY WOULD NOT PROGRAM, BUT SHE REFUSED ASSISTANCE IN PROGRAMMING THE PUMP. THE PATIENT STATED SHE HAS DISCONTINUED INSULIN PUMP THERAPY BUT WOULD NOT STATE IF SHE HAD A BACK-UP PLAN AND REFUSED TO CONTACT HER HEALTH-CARE PROVIDER. THE PATIENT STATED SHE HAS NOT TAKEN AN ALTERNATE FORM OF INSULIN SINCE COMING OFF THE PUMP. THE PATIENT REFUSED ANY ASSISTANCE AND WOULD NOT TROUBLESHOOT THE PUMP. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. HOWEVER THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP WILL NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68827 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR