BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3936314 · Received July 15, 2014

    Report

    Report Number
    1823260-2014-05255
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM (LOT NUMBER AND EXPIRATION DATE UNKNOWN). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM. DEVICE WILL NOT BE RETURNED TO MFR.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A RESULT OF 5.5 MMOL/L ON THE MOBILE SYSTEM, AND A RESULT OF 3.2 MMOL/L ON THE AVIVA SYSTEM WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. THE CUSTOMER CONSUMED A SUGARY DRINK. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER THE TEST STRIPS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412571 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female UNKNOWN INSULIN| UNKNOWN INSULIN PUMP| UNKNOWN INSULIN| UNKNOWN INSULIN PUMP