BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3013296 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02859
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE ALARM HISTORY SHOWS OCCLUSION ALARMS HAD OCCURRED. THE OCCLUSION SENSITIVITY WAS SET TO HIGH. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. REWIND, LOAD, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. NO OCCLUSIONS OCCURRED DURING TESTING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. AN OCCLUSION WAS INDUCED AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERTS. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, INDICATING THAT THE PATIENT WAS HOSPITALIZED FOR 6 DAYS. THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE LEVEL OVER 500MG/DL. THE REPORTER INDICATED THAT THERE WERE NO OCCLUSION ALARMS IN THE HISTORY DESPITE HAVING SITE ISSUES. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115734 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R