BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 2920108 · Received January 17, 2013

    Report

    Report Number
    1823260-2013-00319
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 2, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE NANO SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH THREE DIFFERENT METERS, WITHIN 10 MINUTES: 549 MG/DL AND 123 MG/DL (NANO SYSTEM 1) 89 MG/DL AND 293 MG/DL (NANO SYSTEM 2) 96 MG/DL, 76 MG/DL AND 64 MG/DL (AVIVA) CUSTOMER WAS USING A DIFFERENT STRIP LOT ON EACH SYSTEM. CUSTOMER WAS FEELING LOW BLOOD SYMPTOMS AT THE TIME OF THE RESULTS AND WAS ABLE TO SELF-TREAT. SPECIFICS OF TREATMENT NOT PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25539 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 470846

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR HUMALOG| LANTUS