BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2923958 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00940
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS STATING THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) VALUES AND WENT TO THE HOSPITAL. THE PATIENT'S BG VALUE REPORTEDLY WAS 330MG/DL WITH NO SYMPTOMS. THE PATIENT REPORTEDLY WAS NOT ADMITTED BUT WAS REMOVED OFF THE PUMP AND PUT ON A BACK-UP PLAN. THE PATIENT STATED THAT SHE BELIEVED THAT THE PUMP WAS NOT DELIVERING INSULIN. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND NOTED NO ISSUES WITH THE SETTINGS/PROGRAMMING ISSUES WITH THE PUMP. THERE WERE NO SITE/SET OR CARTRIDGE ISSUES NOTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND TO DUE TO THE ALLEGATION THAT THERE MAY HAVE BEEN A DELIVERY ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30577 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| L| R