BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 4111199 · Received September 23, 2014

    Report

    Report Number
    1823260-2014-07249
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    October 31, 2014
    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. THIS MEDWATCH IS FOR INFORM II SYSTEM 2. REFERENCE MEDWATCH WITH (B)(6) FOR INFORM II SYSTEM 1.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 10 MINUTES: 14.8 MMOL/L (INFORM II SYSTEM 1) AND 6.1 MMOL/L (INFORM II SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590526 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 472743

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR