BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2123290 · Received June 14, 2011

    Report

    Report Number
    1823260-2011-03256
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    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 WARFARIN| COAGULATION METER| WHEELCHAIR| "REGAN"| VITAMIN D| LASIX| HUMULIN INSULIN| ISOSORBIDE