BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 4770982 · Received May 14, 2015

    Report

    Report Number
    3011393376-2015-00297
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    April 13, 2015
    Report Date
    May 18, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 OVER HALF A CARTRIDGE OF INSULIN LEAKED INTO THE INFUSION DEVICE ON (B)(6) 2015. THE INFUSION DEVICE DISPLAYED SEVERAL E10 CARTRIDGE ERRORS THROUGHOUT THE NEXT WEEK, AND HER BLOOD GLUCOSE ELEVATED TO THE 300-400 MG/DL RANGE. ON (B)(6) 2015 AROUND 2:30 P.M., THE CUSTOMER LOST CONSCIOUSNESS. HER HUSBAND CONTACTED THE PARAMEDICS ON (B)(6) 2015 AT 12:00 A.M., AND SHE WAS TRANSPORTED TO THE HOSPITAL. HER BLOOD GLUCOSE WAS 1200 MG/DL AT THE HOSPITAL, AND SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS, ADMITTED TO THE INTENSIVE CARE UNIT, AND PLACED ON LIFE SUPPORT. SHE WAS TREATED WITH INSULIN VIA IV. SHE REGAINED CONSCIOUSNESS IN THE MORNING ON (B)(6) 2015 AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. SHE BELIEVES THE E10 ERRORS, WHICH RESULTED FROM THE LEAKY CARTRIDGE, PREVENTED HER FROM GETTING INSULIN. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315116 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIABETES CARE, INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR Hospitalization| R ENALAPRIL| LATUDA| MULTIVITAMIN| HUMALOG| AMBIEN