BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1881040 · Received October 18, 2010

    Report

    Report Number
    2531779-2010-01731
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 18, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 DRAWN AT THIS TIME. THROUGH INVESTIGATION, THE ANIMAS CDE NOTED THE DEVICE'S ALARM HISTORY REVEALED AN OCCLUSION ALARM ON (B)(6) 2010, AND A (B)(6) ALARM ON (B)(6) 2010. THE ANIMAS CDE WAS UNABLE TO WALK THE PT THROUGH ADDITIONAL TROUBLESHOOTING SINCE THE PT WAS HAVING DIFFICULTY NAVIGATING THROUGH THE PUMP AND READING THE PUMP SCREEN. DURING A FOLLOW-UP MEETING WITH THE PT ON (B)(6) 2010, THE EDUCATOR REVIEWED OCCLUSION ALARMS WITH THE PT AND HAD HIM DEMONSTRATE SITE/SETUP.

    Additional Manufacturer Narrative · 1

    (B)(4): NO PUMP HISTORY FROM THE TIME OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. 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

    THE PT CONTACTED ANIMAS ALLEGING THAT HIS BLOOD GLUCOSE LEVEL WAS AROUND "415 MG/DL" AND HE WAS TREATED WITH LANTUS INSULIN BY A DOCTOR. THE PT CLAIMED THAT HIS DOCTOR TOOK HIM OFF OF THE PUMP AND ADVISED HIM TO GO TO A BACKUP PLAN. AT THE TIME OF THE CALL WITH THE ANIMAS CDE, THE PT'S BLOOD GLUCOSE LEVEL WAS "318 MG/DL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention