BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172809 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08304
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A LOW BLOOD GLUCOSE ON (B)(6) 2013. THE PATIENT WAS TREATED IN THE ICU AND RELEASED ON (B)(6) 2013. THE HEALTHCARE PROFESSIONAL ASKED THAT THE PUMP BE CHECKED. THERE WERE NO CHANGES MADE TO ADVANCED FEATURES AND THEY WERE SET AS DESIRED. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND THERE WERE NO ISSUES FOUND WITH THE PUMP. THE INSULIN WAS REVIEWED AND NO ISSUES FOUND. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273199 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization