BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3848918 · Received June 4, 2014

    Report

    Report Number
    1823260-2014-04003
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    NA
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 119 MG/DL (NANO), SYSTEM 1 AND 272 MG/DL (COMPACT PLUS), SYSTEM 2. CUSTOMER HAD NO SYMPTOMS. NO ACTIONS TAKEN EXCEPT TO RETEST. NO DEATH OR SERIOUS INJURY REPORTED. REQUESTED RETURN OF SUSPECT PRODUCT AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326314 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR NA NA 471791

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR VITAMIN D| LYRICA| LUTEIN| LOSARTAN| LEVEMIR| CRESTOR| CALTRATE| WELCHOL| SINGULAIR| HUMALOG| CENTRUM