BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2830824 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13561
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. NO INSULIN DELIVERY DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. ON (B)(6) 2012 AT 04:36 A "REPLACE BATTERY" ALARM WAS RECORDED IN THE BLACK BOX, THE ALARM WAS NOT CONFIRMED UNTIL 06:09 DAMAGE TO THE PUMP CASE WAS OBSERVED BETWEEN THE BOTTOM LEFT CORNER OF THE DISPLAY LENS AND THE CASE SEAL.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6), 2012 THE PATIENT EXPERIENCED THE SYMPTOM OF VOMITING AND 'HIGH BLOOD GLUCOSE LEVELS', SPECIFIC RESULTS NOT PROVIDED. THE PATIENT WENT TO THE EMERGENCY ROOM, AND SHE WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA. THE PATIENT WAS ADMITTED TO ICU AND TREATED INTRAVENOUSLY WITH INSULIN. THE PATIENT ALSO REPORTED HAVING A HISTORY OF SCAR TISSUE AT HER INFUSION SITES AND ISSUES WITH OCCLUSIONS. TROUBLESHOOTING REVEALED ALL PUMP SETTINGS, PROGRAMMING, BASAL RATE AND DATE/TIME WERE CORRECT. THERE WAS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN AS PROGRAMMED. THE PATIENT'S TECHNIQUE MAY HAVE BEEN INCORRECT BY USING AREAS WITH SCAR TISSUE FOR INFUSIONS. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS OF DKA AND WAS ADMITTED TO THE HOSPITAL WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L