BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1942122 · Received December 30, 2010

    Report

    Report Number
    1823260-2010-07759
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 23, 2010
    Report Date
    February 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 430 MG/DL AND 100-199 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO 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 302759

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR ACTOS| BABY ASPIRIN| CINNAMON HERBAL CAPSULE (DAILY)| IBUPROFEN| FOSINOPRIL (DAILY)| SIMVASTATIN (DAILY)| "NIFE"| HALOPERIDOL (DAILY)| HUMULIN N (SLIDING SCALE)