BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2080804 · Received May 6, 2011

    Report

    Report Number
    2531779-2011-03210
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    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

    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.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO 480 MG/DL WHILE USING THE ANIMAS INSULIN PUMP TO MANAGED HIS/HER BLOOD GLUCOSE. AROUND (B)(6) 2011, THE PATIENT'S BLOOD GLUCOSE WAS IN THE "200'S MG/DL" IN THE MORNING TIME. WHEN THE PATIENT WENT TO SCHOOL, THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO "480 MG/DL" WITH SYMPTOMS OF "NAUSEA, HEADACHE, TIREDNESS, AND KETONES." THE PATIENT DID NOT RESPOND TO CORRECT BOLUS INSULIN VIA THE ANIMAS PUMP. THE PATIENT SUBSEQUENTLY DISCONNECTED FROM THE ANIMAS PUMP AND TOOK INSULIN TREATMENT VIA SYRINGES. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE PROVIDER VERIFIED THAT THE ANIMAS PUMP IS WORKING ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FOR A HYPERGLYCEMIC EPISODE WHILE UTILIZING THE ANIMAS INSULIN PUMP TO MANAGED HIS/HER DIABETES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 Hospitalization| L| R