BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1980858 · Received February 7, 2011

    Report

    Report Number
    1823260-2011-00671
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    December 25, 2010
    Report Date
    February 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER WAS LETHARGIC, COULD NOT SPEAK, AND WAS IMMOBILE WHEN SHE USED HIS COMPACT PLUS SYSTEM TO OBTAIN A RESULT OF 125 MG/DL. REPORTER STATED THAT SHE CALLED THE PARAMEDICS WHO ARRIVED AND TESTED HIM WITH A RESULT OF 27 MG/DL TWENTY MINUTES LATER. REPORTER STATED THEY TREATED THE CUSTOMER WITH GLUCOSE INTRAVENOUSLY AND TOOK THE CUSTOMER TO THE HOSPITAL. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR Required Intervention HUMULIN 70/30| WHEEL CHAIR| LISINOPRIL