BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2800587 · Received October 22, 2012

    Report

    Report Number
    1823260-2012-05304
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6) WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    CALLER REPORTED MOBILE SYSTEM RESULTS OF 60 MG/DL AND 121 MG/DL WITHIN 10 MINUTES. CALLER REPORTED BLOOD GLUCOSE RESULTS OF 55 MG/DL ON MOBILE SYSTEM, 124 MG/DL ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO COMPACT PLUS INFORMATION AVAILABLE. NO ADVERSE EVENT WAS REPORTED. STRIPS NOT AVAILABLE FOR RETURN, 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 278154

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR