BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SMARTVIEW TEST STRIPS

    MDR report key: 3033489 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02029
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR NANO SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 435 MG/DL ON NANO SYSTEM AND 180 MG/DL ON COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO FURTHER TREATMENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137284 ACCU-CHEK ® SMARTVIEW TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471170

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR METFORMIN