BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3190618 · Received June 26, 2013

    Report

    Report Number
    1823260-2013-03865
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    March 27, 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
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF IN THE 300'S MG/DL AND IN THE 290'S MG/DL ON AVIVA SYSTEM 1, 37 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290321 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491368

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male HUMALOG U100| HUMULIN N U100| HUMALOG U100| HUMULIN N U100