BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071394 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04790
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES SHOW THAT THE LAST BASAL AND BOLUS DELIVERIES OCCURRED ON (B)(4) 2013. 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. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    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 REPORTER CONTACTED ANIMAS FOR ASSISTANCE IN DOWNLOADING PUMP INFORMATION AND MENTIONED THAT THE PATIENT'S BLOOD GLUCOSE (BG) THAT MORNING WAS 539MG/DL WITH LARGE KETONES AND THE PATIENT "DID NOT FEEL WELL." THE PATIENT REPORTEDLY CORRECTED WITH AN INSULIN INJECTION AND BG CAME DOWN TO 237MG/DL. THE PATIENT HAD REPORTEDLY CHANGED THE SITE BUT NOT THE TUBING THE PREVIOUS EVENING AND DID NOT CHECK BGS FOR THE REST OF THE EVENING AFTER THE SITE CHANGE. THE REPORTER DENIED SITE/SET ISSUES. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. THE REPORTER WAS UNSURE IF THE ADVANCED SETTINGS WERE CORRECT AND CTS ADVISED THE REPORTER TO CONTACT THE PATIENT'S HEALTHCARE PROVIDER TO CONFIRM ADVANCED SETTINGS. THE PATIENT WAS TO CHANGE THE SITE AND MONITOR BGS WITH THE NEW SITE. THERE WAS NO PUMP DEFECT FOUND DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173068 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening