BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2082436 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03257
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: NOT PROVIDED. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THE PUMP'S INSULIN DELIVERY WAS ACCURATE AND MATCHED THE SETTINGS AS PROGRAMMED BY THE USER. THE PUMP WAS EXERCISED AND ACCURATELY DELIVERED INSULIN AS PROGRAMMED. THE PUMP'S HISTORY REVEALED THE PUMP DELIVERED ALL BASAL/BOLUS INSULIN DOSES ACCURATELY AS PROGRAMMED. THERE WERE NO ALARMS IN THE PUMP HISTORY INDICATIVE OF A MALFUNCTION.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THAT THE INSULIN PUMP WENT INTO A SUSPEND MODE WITHOUT USER INTERVENTION, AND THAT FOR ONE WEEK THE PATIENT'S BLOOD GLUCOSE LEVELS WERE "IN THE 400'S MG/DL". DURING THIS TIME PERIOD, THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA, THIRST AND DRY MOUTH. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PUMP HISTORY REVEALED MULTIPLE SUSPENDS; HOWEVER, THE PATIENT CLAIMED SHE ONLY SUSPENDED THE PUMP ONCE PER DAY. PRODUCT ANALYSIS OF THE PUMP INDICATED THE INSULIN DELIVERY WAS CORRECT AS PROGRAMMED. THERE IS NO EVIDENCE THE PUMP WAS NOT FUNCTIONING APPROPRIATELY. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening