BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1914125 · Received December 3, 2010

    Report

    Report Number
    1823260-2010-07145
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 3, 2010
    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

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED TAKING 8 UNITS OF NOVOLOG BASED UPON A COMPACT PLUS RESULT OF 464 MG/DL. SHE PASSED OUT 15 MINUTES LATER, REQUIRING TREATMENT WITH ORANGE JUICE FROM PHARMACY EMPLOYEES. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    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
    1 035 YR Required Intervention LANTUS| LEXAPRO| NOVOLOG