BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3210726 · Received July 8, 2013

    Report

    Report Number
    1823260-2013-04085
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 9, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE MOBILE SYSTEM. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE AVIVA SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 10 MINUTES: 24.0 MMOL/L, 10.0 MMOL/L AND 22.0 MMOL/L (MOBILE SYSTEM) AND 8.0 MMOL/L (AVIVA SYSTEM). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. ON A DIFFERENT DAY, REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 3.7 MMOL/L, 21.5 MMOL/L AND 5.2 MMOL/L. CUSTOMER SELF-TREATED WITH DEX4 TABLETS BASED ON THE 3.7 MMOL/L RESULT. 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
    311203 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278211

    Patients

    Seq Age Sex Outcome Treatment
    1 011 YR LEVEMIR - 1X A DAY| NOVORAPID - 1X A DAY