BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3032796 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02008
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    CALLER STATES A NEONATE PATIENT TESTED 1.9 MMOL/L ON THE INFORM SYSTEM WHILE COMPARISON LABS RETURNED AS 3.3 MMOL/L AND 1.7 MMOL/L WITHIN 10 MINUTES. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137014 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1