BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2100889 · Received May 24, 2011

    Report

    Report Number
    1823260-2011-02751
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 24, 2011
    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
    GB
    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 HAS LOW BLOOD GLUCOSE SYMPTOMS WITH RESULT OF 13.6 MMOL/L OBTAINED ON THE MOBILE SYSTEM AT 17:30. 19 MINUTES LATER CUSTOMER TESTED 3.9 MMOL/L ON THE MOBILE SYSTEM AND CALLER CONTACTED AN AMBULANCE. CUSTOMER RECEIVED UNSPECIFIED MEDICAL TREATMENT BY AMBULANCE PERSONNEL AND WAS TAKEN TO THE HOSPITAL. AT 19:50, CUSTOMER TESTED 11.0 MMOL/L ON THE MOBILE SYSTEM WHILE A LAB VALUE RETUNED AS 6.0 MMOL/L. CUSTOMER WAS ADMITTED TO THE HOSPITAL; CURRENT CONDITION IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 277028

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR Hospitalization| O NOVORAPID| LANTUS AT BEDTIME