BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2820415 · Received November 6, 2012

    Report

    Report Number
    1823260-2012-05626
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF 117 MG/DL AND 17 MG/DL, WITHIN 2 MINUTES, ON THE ACCU-CHEK AVIVA SYSTEM. NO ACTION BASED ON DEVICE RESULTS WAS REPORTED AND NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490873

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR