BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242933 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11744
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THERE WERE THREE INCIDENTS WHERE THE PUMP WAS NOT DELIVERING INSULIN SINCE APRIL. THE REPORTER STATED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2013. THE REPORTER STATED THAT THE PATIENT WOKE UP THE MORNING OF (B)(6) 2013 WITH A BLOOD GLUCOSE (BG) IN THE 400¿SMG/DL WITH LARGE KETONES. THE REPORTER STATED SHE CALLED HER ENDOCRINOLOGIST AND CHANGED OUT SITE. THE PATIENT WAS TREATED WITH NOVOLOG AND BG CAME DOWN TO 200MG/DL. LATER THAT DAY THE BG CLIMBED BACK TO 400¿S MG/DL WITH VOMITING. THE PATIENT WAS THEN TAKEN TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED WITH IV BOLUS OF NORMAL SALINE AND INSULIN INJECTIONS. THE REPORTER STATED THAT THE PATIENT RESPONDED VERY WELL AND HER BLOOD SUGAR DROPPED. THE VALUE WAS UNKNOWN AND NOT PROVIDED. THE PATIENT WAS STABILIZED AND RELEASED EARLY MORNING NEXT DAY WITH BG 100'S MG/DL. THE REPORTER STATED THAT THE PATIENT WAS CONNECTED TO THE PUMP DURING MOST OF THE EMERGENCY ROOM VISIT. 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
    343482 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization