BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT CARTRIDGE

    MDR report key: 4635095 · Received March 26, 2015

    Report

    Report Number
    1823260-2015-02459
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    March 2, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. CUSTOMER HAD TWO LOT NUMBERS OF CARTRIDGES AT THE TIME THE LEAK OCCURRED AND IT IS UNKNOWN WHICH LOT WAS IN USE. THE TWO LOTS ARE 1083535, EXPIRATION DATE 05/31/2015 AND 1083536, EXPIRATION DATE 08/31/2015. WHILE THE SUSPECT DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION, THE MANUFACTURER HAS CONFIRMED THE ALLEGATION BASED ON THE LOT NUMBERS OF THE CARTRIDGES THE CUSTOMER HAD IN USE AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED THAT IN THE AFTERNOON HER BLOOD GLUCOSE VALUES WERE HIGH (300/350 MG/DL) AND THE CARTRIDGE COMPARTMENT WAS WET. SHE STATED THAT IT PRESENTED AS AN INSULIN LEAK INSIDE THE CARTRIDGE. NO ADVERSE EVENT REPORTED. CARTRIDGE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204174 ACCU-CHEK ® INSIGHT CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 1083535

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED INSULIN