BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173757 · Received July 24, 2011

    Report

    Report Number
    2531779-2011-05174
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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

    ON (B)(6) 2011 THE REPORTER, THE PATIENT'S MOTHER, REPORTED THAT ON (B)(6) 2011 THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "HI MG/DL" (GREATER THAN 600 MG/DL) AND SHE EXPERIENCED THE SYMPTOM OF CONFUSION. THE PATIENT'S MOTHER FOUND THE PUMP POWERED OFF AND THE PATIENT WAS DISCONNECTED FROM THE PUMP. EARLIER ON (B)(6), THE PATIENT HAD RECEIVED A MORNING BASAL DOSE OF 1.875 UNITS INSULIN, AND THE PUMP GAVE THE LOW BATTERY ALARM. THE PUMP HISTORY REVEALED THE ALARMS WERE GIVEN, HOWEVER THE PATIENT DID NOT RESPOND TO THE ALARMS, AND DID NOT REPLACE THE PUMP BATTERY. THE PATIENT RECEIVED NO OTHER DOSES OF INSULIN THAT DAY. THE PATIENT'S MOTHER CONTACTED EMERGENCY SERVICES, AND PARAMEDICS TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 1900 MG/DL, SHE WAS TREATED WITH INTRAVENOUS INSULIN AND FLUIDS, AND ADMITTED TO THE HOSPITAL FOR FOUR DAYS. THE PUMP WAS FOUND TO BE FUNCTIONING APPROPRIATELY AND GAVE THE LOW BATTERY ALARMS. THE PATIENT IGNORED THE ALARMS AND DID NOT REPLACE THE BATTERY. AFTERWARDS, THE PATIENT SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA, AND WAS ADMITTED TO THE HOSPITAL AND RECEIVED EMERGENCY TREATMENT. THEREFORE 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 30 YR Hospitalization| L