BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3924689 · Received July 10, 2014

    Report

    Report Number
    1823260-2014-05068
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 28, 2025
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 11.3 MMOL/L, 12.7 MMOL/L, 5.7 MMOL/L, AND 4.2 MMOL/L. THE CUSTOMER REPORTED FEELING DIZZY WITH THESE RESULTS. HER CONDITION IMPROVED ONE HOUR LATER. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402959 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493513

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female "INSUMAN"| "PENAZEPRIL"| EMSELEX| METFORMIN| SIMVASTATIN| THYROX| "PENAZEPRIL"| EMSELEX| SIMVASTATIN| THYROX| "INSUMAN"| METFORMIN