BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1801824 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04854
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 50 MG/DL, 95 MG/DL AND 90 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE HI/LOW FUNCTION WILL NOT LOWER. THE TRENDELENBURG AND REVERSE TRENDELENBURG IS WORKING BUT WHEN THE SWITCH IS RELEASES, THE BED RUNS BACK UP ON ITS OWN.

    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 302304

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR VITAMIN D| ALLOPURINOL| HYDROCODONE (4 TIMES DAILY)| VITAMIN B12| ACETAMINOPHEN (AS NEEDED)| ASPIRIN| GENERIC FOR ALLEGRA (DAILY)| METOPROLOL| TEKTURNA| ACIPHEX (DAILY)| EQUALINE| LISINOPRIL| NOVOLOG| LANTUS