BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 4171645 · Received October 14, 2014

    Report

    Report Number
    1823260-2014-07890
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 28, 2014
    Report Date
    November 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. MEDWATCH WITH IDENTIFIER (B)(6) IS MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS PERFORMA SYSTEM.

    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. MEDWATCH WITH IDENTIFIER (B)(6) IS MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS PERFORMA SYSTEM. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY CASSETTE WAS RETURNED.

    Description of Event or Problem · 1

    CALLER REPORTED A SEPARATE COMPARISON OF 545 MG/DL ON MOBILE SYSTEM, 131 MG/DL ON PERFORMA SYSTEM WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650054 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278304

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR "LENTHUS BYETTA"| LEVEMIR| NOVORAPID