BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 4131589 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07486
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE RECEIVED THE FOLLOWING RESULTS ON THE NANO SYSTEM WITHIN 2 MINUTES: 163 MG/DL, 141 MG/DL, 122 MG/DL, 109 MG/DL, AND 90 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION; HOWEVER, THE SUSPECT STRIPS HAVE BEEN USED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613011 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473297

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR HUMULIN NPH| HUMULIN R