BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MOBILE TEST STRIPS

    MDR report key: 1971979 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00495
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 10, 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). ACCU-CHEK COMPACT METER SERIAL NUMBER (B)(4) ACCU-CHEK COMPACT TEST STRIP LOT NUMBER 207242C, EXPIRATION DATE 04-2011.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). ACCU-CHEK COMPACT METER SERIAL NUMBER (B)(4) ACCU-CHEK COMPACT TEST STRIP LOT NUMBER 207242C, EXPIRATION DATE 04-2011. DEFECTIVE RFID CHIP CAUSED AN E2 ERROR.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 246 MG/DL ON MOBILE SYSTEM, 104 MG/DL AND 107 MG/DL ON COMPACT SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE 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 277038

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR