BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3061787 · Received April 16, 2013

    Report

    Report Number
    1823260-2013-02322
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    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
    IL, 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.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 371 MG/DL, 268 MG/DL, AND 138 MG/DL 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
    162459 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491607

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male GLYBURIDE 2X A DAY| HUMALOG| JANUVIA 1X A DAY| LANTUS 1XDAY| METFORMIN 1XDAY| WALKER| WALKER| HUMALOG| METFORMIN 1XDAY| JANUVIA 1X A DAY| LANTUS 1XDAY| GLYBURIDE 2X A DAY