BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 3770103 · Received April 24, 2014

    Report

    Report Number
    1823260-2014-03016
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    ON (B)(6) 2014, THE PATIENT REPORTED THAT HER INSULIN CARTRIDGE WAS LEAKING WHEN SHE FILLS IT. SHE STATED THAT SHE HAS HAD THIS PROBLEM WITH TWO CARTRIDGES FROM THE SAME BOX AND HAS NOT EXPERIENCED ANY PROBLEMS FROM CARTRIDGES FROM OTHER BOXES. NO ADVERSE EVENT WAS REPORTED. THE INSULIN CARTRIDGES WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248643 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 32494222

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR SYNTHROID| CITALOPRAM| HUMALOG| BABY ASPIRIN| CRESTOR