BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3202983 · Received July 2, 2013

    Report

    Report Number
    1823260-2013-04009
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 2, 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.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS ON MOBILE SYSTEM COMPARED TO A PROFESSIONAL METER WITHIN 8 MINUTES AND 1 MINUTE RESPECTIVELY: 417 MG/DL (MOBILE SYSTEM) AND 159 MG/DL (PROFESSIONAL METER); 493 MG/DL (MOBILE SYSTEM) AND 147 MG/DL (PROFESSIONAL METER). SETS OF RESULTS WERE TAKEN AT DIFFERENT TIMES. 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
    300990 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278215

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR JANUVIA| DIAMICRON| INSULATARD FLEXPEN| CORTISONE| XELOX| "CHEMO INFUSION"