BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2183114 · Received July 28, 2011

    Report

    Report Number
    1823260-2011-04058
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). NO INFORMATION PROVIDED FOR THE COMPACT SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 340 MG/DL ON CUSTOMER'S MOBILE SYSTEM, 158 MG/DL ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO INFORMATION PRIVUDED FOR THE COMPACT SYSTEM. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METERS AND STRIPS, REPLACEMENT 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 278009

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR