BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2841211 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13821
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): NO DEFECT WAS FOUND. TESTING WAS UNABLE TO CONFIRM OR DUPLICATE COMPLIANT DURING THE INVESTIGATION. REVIEW OF THE BLACK BOX AND ALARM HISTORY SHOW NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT. ALL KEYS ARE RESPONSIVE TO USER INPUT. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. REVIEW OF THE DAILY INSULIN DELIVERY TOTALS SHOWS PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED.

    Description of Event or Problem · 1

    THE REPORTER, WHO WAS A HEALTHCARE PROVIDER, CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE DEMO PUMP WAS NOT DELIVERING INSULIN PROPERLY. THE REPORTED STATED THAT PATIENTS HAD COMPLAINED THAT WHILE USING THE PUMP, BLOOD GLUCOSE (BG) LEVELS WERE HIGH EVEN AFTER CHANGING THE INFUSION SET AND TROUBLESHOOTING THE PUMP. NO MEASUREMENTS OF HIGH BG LEVELS WERE PROVIDED AND NO ASSOCIATED SYMPTOMS WERE MENTIONED. THE HEALTHCARE PROVIDER REQUESTED THE PUMP BE REPLACED. SEVERAL ATTEMPTS WERE MADE BY MEDICAL SURVEILLANCE TO REACH THE REPORTER IN AN ATTEMPT TO CLARIFY THE REPORT OF PATIENTS COMPLAINTS OF HIGH BGS, BUT THE REPORTER DID NOT RESPOND TO THE INQUIRIES. BASED ON THE INFORMATION RECEIVED FROM THE REPORTER, THE ELEVATED BGS REPORTED DO NOT MEET ANIMAS CRITERIA OF A SERIOUS ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE A HEALTHCARE PROVIDER ALLEGED MALFUNCTION OF THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1