BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2911070 · Received January 11, 2013

    Report

    Report Number
    1823260-2013-00249
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 21, 2012
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. CUSTOMER DISCONNECTED BEFORE A REQUEST COULD BE MADE FOR THIS INFORMATION. AFTER REPEATED ATTEMPTS TO REACH THE CUSTOMER, THE AGENT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: A RESULT OF "300 OR 350" MG/DL AND A RESULT OF "60 OR 70" MG/DL. NO ACTIONS TAKEN REPORTED BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CUSTOMER DISCONNECTED BEFORE PRODUCT WAS REQUESTED FOR RETURN. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16544 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female