BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3033757 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02036
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 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.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 418 MG/DL, HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, 170 MG/DL, AND 146 MG/DL WITHIN 10 MINUTES. HE WASHED HIS HANDS AFTER THE 170 READING AND BEFORE 146 READING. HE SAID HE HAD ORANGE JUICE ON HIS HANDS FOR THE READINGS OF 418, HI, AND 170. 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
    135774 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490755

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male NOVOLOG FLEX PEN 70/30| NOVOLOG FLEX PEN 70/30