BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3942094 · Received July 17, 2014

    Report

    Report Number
    1823260-2014-05332
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 13.0 MMOL/L AND 6.0 MMOL/L WITHIN 10 MINUTES ON THE PERFORMA SYSTEM USING INFORM II STRIPS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418428 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 472148

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR LIPEX AT NIGHT| BETALOC IN THE AM