BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1971859 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00492
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 18, 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 357 MG/DL AND 108 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED SHE TOOK HER NORMAL MEDICATIONS, DOCUMENTED AS 500 MG OF METFORMIN JUST OVER AN HOUR PRIOR TO OBTAINING THE RESULTS. 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 302997

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR METHOTREXATE| FOLIC ACID| DIOVAN (DAILY)| METFORMIN| LEVOTHYROXINE| GABAPENTIN| REMICADE| CALCIUM/VITAMIN D| ACIPHEX (DAILY)| SIMVASTATIN| AMBIEN