BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2911082 · Received January 11, 2013

    Report

    Report Number
    1823260-2013-00246
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    February 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 27.0 OR 28.0 MMOL/L AND 4. "SOMETHING" (MMOL/L) WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. ON A DIFFERENT DATE, CUSTOMER REPORTED "ODD" AND HER SPEECH WAS "GONE" SO HER DAUGHTER CALLED PARAMEDICS. CUSTOMER TESTED 7.2 MMOL/L ON THE AVIVA SYSTEM; 30 MINUTES LATER PARAMEDICS TESTED HER ON THE PROFESSIONAL METER AND THE RESULT WAS 1.4 OR 1.2 MMOL/L. CUSTOMER RECEIVED PROFESSIONAL MEDICAL TREATMENT, BUT DOES NOT RECALL WHAT TREATMENT SHE RECEIVED. PARAMEDICS LEFT ONCE CUSTOMER'S BLOOD GLUCOSE REACHED "ABOUT" 5 MMOL/L. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16572 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490459

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR Required Intervention