BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1930798 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07528
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 10, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 184 MG/DL AND 49 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT SHE ATE HER BREAKFAST AS SHE NORMALLY WOULD. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 302076

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR LISINOPRIL| NOVOLOG (SLIDING SCALE)| METFORMIN (TWICE DAILY)| LANTUS (DAILY)