BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2914202 · Received January 14, 2013

    Report

    Report Number
    1823260-2013-00283
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    June 1, 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
    TX, 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. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. REFERENCE MEDWATCH WITH (B)(6) FOR THE AVIVA SYSTEM 1. DEVICE WILL NOT BE RETURNED

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 63 MG/DL (AVIVA SYSTEM 1) AND 18 MG/DL (AVIVA SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECTED DEVICE AND STRIPS; HOWEVER, CUSTOMER HAS USED UP AND DISCARDED STRIPS. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21710 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female CRESTOR| HUMALOG| LAVASI| LISINOPRIL| CRESTOR| LAVASI| HUMALOG| LISINOPRIL