BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1790736 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04715
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 16, 2010
    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

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 171 MG/DL AND 95 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK AVIVA SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (GTS). THE HOME PATIENT (HP) STATED SHE BELIEVED SHE HAD AIR GO INTO HER. IT WAS EXPLAINED THE HP MIGHT HAVE RECEIVED THE AIR FROM THE PATIENT LINE IF IT HAD NOT BEEN FULLY PRIMED BEFORE CONNECTING. GTS SPOKE WITH THE NURSE AS WELL AND THE NURSE WAS GOING TO HAVE THE HP COME INTO THE CLINIC. THE CAUSE WAS UNDETERMINED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 302363

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR MIRTAZAPINE 1XDAY| TRIAMTERENE| NOVOLOG| VITAMIN D| VENLAFAXINE| CALCIUM| SOMAVERT| WARFARIN| LANTUS| GLIPIZIDE| HEARING AID| RANITIDINE 1XDAY| HCTZ| ATENOLOL| LISINOPRIL| TAMSULOSIN