BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3070935 · Received April 22, 2013

    Report

    Report Number
    1823260-2013-02445
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 22, 2013
    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. THIS MEDWATCH IS FOR MOBILE SYSTEM 2 WITH STRIP LOT 278171. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR MOBILE SYSTEM 1 WITH STRIP LOT 278103.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON TWO DIFFERENT METERS WITHIN 3-4 MINUTES: HI (RESULT OVER 600 MG/DL (MOBILE SYSTEM 1) AND 140 MG/DL (MOBILE SYSTEM 2). READINGS OCCURRED WITH TWO DIFFERENT LOTS OF TEST STRIPS. CUSTOMER IS NOT SURE WHICH LOT PRODUCED WHICH RESULT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172817 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278171

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR