BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3230236 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11015
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 09/30/2015-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA SHOWED THAT THE LAST BOLUS DELIVERY AND THE LAST BASAL DELIVERY WERE ON 08/22/2013. NO ALARMS RELATED TO THE COMPLAINT WERE OBSERVED IN THE ALARM HISTORY. DURING TESTING, THE PUMP WAS EXERCISED FOR THE 24 HOUR DURATION WITH NO WARNINGS OR ALARMS OCCURRING. THE TOTAL DAILY DOSE DATA WAS CORRECTLY CALCULATED AND REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THE PUMP PERFORMED THE DELIVERY ACCURACY TEST SUCCESSFULLY AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE COMPLAINT OF AN INACCURATE DELIVERY ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS DISCOLORED. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 THE (B)(6) 2013, THE LAY-OUT/PATIENT CONTACTED ANIMAS TO REPORT A POTENTIAL INACCURATE DELIVERY ISSUE. THE PATIENT WANTED TO UPGRADE HER INSULIN PUMP BECAUSE SHE REPORTEDLY IS EXPERIENCING BLOOD GLUCOSE EXCURSION. ANIMAS HAS MADE 3 ATTEMPTS TO CONTACT THE PATIENT BACK FOR MORE INFORMATION. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALL BACK. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328590 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR