BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3083358 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02631
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 29, 2013
    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. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278222, EXPIRATION DATE 08/31/2014). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE PERFORMA NANO SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE MOBILE/PERFORMA NANO SYSTEM: HI (GREATER THAN 600 MG/DL) 3:53 PM (MOBILE), 109 MG/DL 3:57 PM (MOBILE), 497 MG/DL 4:03 PM (MOBILE ), 70 MG/DL 4:08 PM (PERFORMA NANO). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185549 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278222

    Patients

    Seq Age Sex Outcome Treatment
    1 008 YR