BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3011253 · Received March 19, 2013

    Report

    Report Number
    1823260-2013-01654
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE AVIVA SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 261 MG/DL (AVIVA SYSTEM 1) AND 98 MG/DL (AVIVA SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113810 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490760

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male AMARYL 2X DAILY| FLOMAX| METFORMIN 2X DAILY| PROZAC 1X DAILY| METFORMIN 2X DAILY| AMARYL 2X DAILY| PROZAC 1X DAILY| FLOMAX