BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2060728 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02379
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. CARTRIDGE LOT# B201583. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH, THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT# B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/19/2013 WITH THE FOLLOWING FINDINGS: INFORMATION FROM THE REPORTED EVENT DATE IS OVERWRITTEN IN THE BLACK BOX, ALL ¿LOSS OF PRIME¿ WARNINGS IN THE BLACK BOX RECORDS ARE DUE A CARTRIDGE CHANGE, NO ACTIVITY OUTSIDE OF NORMAL USE IS OBSERVED. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECT THE PROGRAMMED BASAL RATE TARGET. THE PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. THE PUMP WAS PRIMED AND EXERCISED FOR 24H, NO DELIVERY INTERRUPTION OCCURRED. THE UNIT PASSED A 29H FLOW ACCURACY TEST SUCCESSFULLY. THE PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE FORCE SENSOR CIRCUIT.

    Description of Event or Problem · 1

    THE REPORTER, THE PT'S MOTHER, REPORTED, THE PT OBTAINED ELEVATED BLOOD GLUCOSE READINGS RANGING FROM 240 MG/DL TO 410 MG/DL AND HAD TRACE URINARY KETONES. DURING THIS TIME PERIOD, THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PT CORRECTED HER BLOOD GLUCOSE LEVELS USING THE PUMP, AND DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THERE WERE NO KINKS OR LEAKS SEEN IN THE TUBING, BUT THE PT DID NOTICE A STRONG SMELL OF INSULIN IN THE CARTRIDGE COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORP ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1