BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3073167 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04916
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013. DEVICE 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. REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED LOSS OF PRIME WARNINGS ON (B)(6) 2013 AT 11:01. DELIVERIES WERE NOT RESUMED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OVER 200MG/DL WITH KETONES WHILE ON A BACK-UP PLAN FOR INSULIN DELIVERY. THE PUMP WAS REPORTEDLY BEING REPLACED AND THE PATIENT WAS ON A BACK-UP PLAN AWAITING DELIVERY OF THE REPLACEMENT PUMP. THE REPORTER WAS ADVISED TO CONTACT THE PATIENT'S HEALTHCARE PROVIDER FOR TREATMENT OF THE ELEVATED BG. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON A BACK-UP PLAN FOR INSULIN DELIVERY WHILE AWAITING A PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175527 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening