BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3021141 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01841
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES CUSTOMER TESTED 6.9 MMOL/L ON THE COMPACT PLUS SYSTEM. SHE ATE BREAKFAST WHICH INCLUDED ONE TOAST WITH JAM AND A SMALL AMOUNT OF APPLE JUICE. CUSTOMER ADMINISTERED THE USUAL DOSE OF 16 UNITS OF NOVOMIX 30. APPROXIMATELY 30 MINUTES AFTER TESTING 6.9 MMOL/L, THE CUSTOMER FELT AS THOUGH SHE WERE ABOUT TO FAINT; AN AMBULANCE WAS CALLED, AND SHE TESTED 1.4 MMOL/L ON THE PROFESSIONAL METER. CUSTOMER WAS TREATED WITH A GLUCOSE GEL CALLED HYPOSTOP AND HER LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124504 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208067

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR Required Intervention NOVOMIX 30