BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 3953109 · Received July 23, 2014

    Report

    Report Number
    1823260-2014-05456
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 30, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INSULIN HAS LEAKED FROM THE CARTRIDGE INTO THE INFUSION DEVICE FOR THE PAST 3 MONTHS. THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL ON (B)(6) 2014 AFTER SHE CHANGED THE CARTRIDGE, AND SHE FELT SWEATY. SHE NOTICED A LARGE AMOUNT OF INSULIN IN THE INFUSION DEVICE AND DRIED THE CARTRIDGE COMPARTMENT WITH A PAPER TOWEL. SHE DELIVERED SEVERAL BOLUSES AND HER BLOOD GLUCOSE DECREASED TO 83 MG/DL BY 5:49 P.M. ON (B)(6) 2014. HER NORMAL RANGE IS 126-149 MG/DL. THE CUSTOMER'S HUSBAND DOES NOT BELIEVE THE LEAK WAS CAUSED BY THE CARTRIDGES BECAUSE IT'S BEEN AN ONGOING ISSUE. THE INFUSION DEVICE, CARTRIDGE, AND ADAPTER WERE REPLACED AND REQUESTED FOR EVALUATION. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432235 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 32066144

    Patients

    Seq Age Sex Outcome Treatment
    1