BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2123292 · Received June 14, 2011

    Report

    Report Number
    1823260-2011-03257
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(6).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 228 MG/DL ON AVIVA SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 118 MG/DL ON AVIVA SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. 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 303222

    Patients

    Seq Age Sex Outcome Treatment
    1 085 YR VITAMIN D| WHEELCHAIR| "REGAN"| LASIX| HUMULIN N| COAGUALATION METER| ISOSORBIDE| WARFARIN