BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1925710 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07440
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 20, 2010
    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 PLUS.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 538 MG/DL ON MOBILE SYSTEM, 216 MG/DL ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. 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 MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 27702431

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR PRAVASTATIN| ASS 100| THYRONAJOD| HCT HEXAL| ALTHEMOL