BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2110533 · Received June 1, 2011

    Report

    Report Number
    1823260-2011-02914
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 511 MG/DL AND 44 MG/DL WITHIN 10 MINUTES. CUSTOMER SELF-TREATED WITH FOOD, FELT BETTER. RETEST RESULT 10 MINUTES LATER WAS 55 MG/DL. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303174

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR LANTUS| BIRTH CONTROL PILLS| HUMALOG