BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1801421 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04834
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM LOCKED UP AND WOULD NOT PRODUCE X-RAYS. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 42 MG/DL, 45 MG/DL, AND 46 MG/DL MG/DL ON THE AVIVA SYSTEM 1, 85 MG/DL AVIVA SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METERS 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 302312

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR NOVOLOG| SYNTHROID| DIOVAN| VICTOZA| LANTUS 2XDAY