BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1371860 · Received February 16, 2009

    Report

    Report Number
    1823260-2009-01252
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    January 15, 2009
    Report Date
    February 16, 2009
    Manufacturer
    OCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 54 MG/DL AND 103 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR OCHE DIAGNOSTICS 301508

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR LEVOTHYROXIN 125 MG/DAY - 1.5 YEARS| TRIAM-HCTZ 37-525/DAY - 7 MONTHS| LISINOPRIL 40 MG/DAY - 1.5 YEARS| METFORMIN 500 MG/4/DAY - 5 YEARS| CRESTOR 5 MG/DAY - 1 YEAR| HUMULIN 6 UNITS/PM - 19 YEARS| HUMULIN 28 UNITS/AM - 19 YEARS