BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3102859 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06100
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. A (B)(4) FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO EVIDENCE OF MOISTURE OBSERVED IN BATTERY COMPARTMENT. NO LEAKS FOUND DURING LEAK TESTING. PUMP WAS OPENED AND NO EVIDENCE OF INTERNAL MOISTURE DAMAGE WAS FOUND. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2013, THE PATIENT HAD ELEVATED BLOOD GLUCOSE (BG) ALL DAY WITH NAUSEA AND VOMITING AND WAS TAKEN TO THE ER. THE PATIENT WAS REPORTEDLY HYDRATED OVERNIGHT AND DISCHARGED THE MORNING OF (B)(6) 2013. NO BG VALUES WERE PROVIDED. THE PATIENT THEN REPORTEDLY CONTINUED TO HAVE ELEVATED BG ON (B)(6) 2013 AND WAS TAKEN BACK TO THE ER WITH BG OF 580MG/DL AND DIABETIC KETOACIDOSIS. THE PATIENT WAS REPORTEDLY REMOVED FROM THE PUMP AND PLACED ON AN INSULIN DRIP. AFTER RETURNING TO THE ER ON (B)(6) 3013, THE PATIENT ADMITTED TO SEEING MOISTURE IN THE BATTERY COMPARTMENT ON (B)(6) 2013. THERE WAS NO PHYSICAL DAMAGE NOTED TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY AFTER MOISTURE WAS NOTED TO BE IN THE BATTERY COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203351 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR