BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1894407 · Received November 9, 2010

    Report

    Report Number
    1823260-2010-06671
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 216 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 112 MG/DL ON THE PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALSO ALLEGED THAT SHE DRANK ORANGE JUICE FORTY MINUTES PRIOR TO THE READINGS AND SHE ATE A SANDWICH JUST PRIOR TO OBTAINING THE READINGS. 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 302562

    Patients

    Seq Age Sex Outcome Treatment
    1 SINGULAIR| FLUOXETINE| METOLAZONE| KLOR-CON| "TRINTARENE"| GLIPIZIDE| OMERPRAZOLE| VENTOLIN| FORADIL