BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1982819 · Received February 9, 2011

    Report

    Report Number
    1823260-2011-00735
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER MADE NO ATTEMPT TO OBTAIN THIS INFORMATION. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF 300 MG/DL AND 150 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 303015

    Patients

    Seq Age Sex Outcome Treatment
    1 090 YR BUPROPION (DAILY)| PANTOPRAZOLE (DAILY)| LANTUS| NOVOLIN R| HYDROXYZINE (DAILY)| DONEPEZIL (DAILY)| "BARLEBO" (DAILY)| CINACALCET (DAILY)