BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3252722 · Received July 29, 2013

    Report

    Report Number
    1823260-2013-04533
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    April 12, 2013
    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). THIS MEDWATCH IS FOR THE AVIVA SYSTEM. REFERENCE MEDWATCH WITH (B)(6) FOR THE MOBILE SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 3 MINUTES: 425 MG/DL (MOBILE SYSTEM) AND 120 MG/DL (AVIVA SYSTEM). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352637 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female LEVEMIR - 1X A DAY| NOVORAPID| NOVORAPID| LEVEMIR - 1X A DAY