BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3843587 · Received June 2, 2014

    Report

    Report Number
    1823260-2014-03926
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    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
    VT, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6). IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE STRIPS WERE RETURNED IN A PLASTIC BAG RATHER THAN IN THE STRIP VIAL. PER THE ACCU- CHEK AVIVA PACKAGE INSERT, IN THE "STORING AND HANDLING THE TEST STRIPS" SECTION, IT STATES, "KEEP THE TEST STRIPS IN THEIR ORIGINAL CONTAINER WITH THE CAP CLOSED. CLOSE THE CONTAINER TIGHTLY RIGHT AFTER YOU TAKE A TEST STRIP OUT. THIS HELPS KEEP THE TEST STRIPS DRY. MOISTURE CAN DAMAGE THE TEST STRIPS AND LEAD TO A WRONG RESULT". CUSTOMER RETURNED STRIPS IN A PLASTIC BAG. STRIPS HAVE BEEN HANDLED IN AN UNAPPROVED MANNER AS DOCUMENTED IN APPLICABLE LABELING; THEY HAVE BEEN COMPROMISED BY LEAVING THEM EXPOSED TO THE ENVIRONMENTAL CONDITIONS. MOISTURE WILL DAMAGE THE TEST STRIPS AND LEAD TO WRONG RESULTS AND/OR STRIP ERRORS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON TWO SEPARATE AVIVA SYSTEMS WITHIN 10 MINUTES: ON THE FIRST SYSTEM 208 MG/DL AND ON THE SECOND SYSTEM 201 MG/DL AND 97 MG/DL. 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
    322398 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male LANTUS| NOVOLOG| NOVOLOG| LANTUS