BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3182365 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08737
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/24/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE TOTAL DAILY INSULIN DELIVERY TOTALS WERE INCONSISTENT DUE TO AN UNRELATED TIME AND DATE ISSUE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) BETWEEN 300MG/DL AND 400MG/DL WITH KETONES FOR THE PAST WEEK. THE PATIENT¿S HEALTHCARE PROVIDER REPORTEDLY ADVISED THE PATIENT TO COME OFF THE PUMP. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT WAS ON AN ALTERNATE FORM OF INSULIN DELIVERY AND HER BG WAS 101MG/DL. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS WERE CORRECT. A REVIEW OF THE ALARM HISTORY SHOWED A REPLACE BATTERY ALARM OCCURRED ON (B)(6) 2013. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE ON INSULIN PUMP THERAPY. IT IS UNKNOWN AT THIS TIME IF THE PUMP WAS A CAUSE OR CONTRIBUTOR IN THE REPORTED BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283164 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening