BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201007 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09473
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/11/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. ONE OCCLUSION DURING PRIME ALARM OBSERVED IN PUMP HISTORIES. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE AT 5LBS. PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO OCCLUSIONS OCCURRED DURING TESTING. AN OCCLUSION WAS INDUCED AND PUMP GIVES THE APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED" ALARM. 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

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PATIENT CONTACTED ANIMAS IN WRITING RECEIVED (B)(6) 2013 ALLEGING THE PUMP DID NOT ALARM FOR OCCLUSION AS IS SHOULD HAVE WHEN THE INFUSION SET CANNULA WAS BENT AND NOT DELIVERING INSULIN AS IT SHOULD HAVE. THE PATIENT STATED THAT AS A RESULT OF THE BENT CANNULAS, SHE HAD ELEVATED BLOOD GLUCOSE (BG) OVER 400 MG/DL WITH HEADACHE AND NAUSEA AND REPORTED BEING HOSPITALIZED IN (B)(6) 2013. THE PATIENT REPORTED BEING DISCONTINUED FROM INSULIN PUMP THERAPY AND BEING TREATED WITH IV INSULIN DRIP WHILE HOSPITALIZED. THE PATIENT STATED HER BG WAS ABLE TO BE PROPERLY CONTROLLED WITH MANUAL INSULIN INJECTIONS WHILE HOSPITALIZED. THE PUMP IS NOT BEING RETURNED TO ANIMAS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS HOSPITALIZED FOR ELEVATED BG WHILE ON INSULIN PUMP THERAPY WITH A PUMP THAT ALLEGEDLY DID NOT PROPERLY ALARM FOR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301688 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R