BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3100270 · Received May 8, 2013

    Report

    Report Number
    1823260-2013-02811
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 11, 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
    GA, 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. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE STRIPS RETURNED OUTSIDE OF THE VIAL.

    Description of Event or Problem · 1

    CUSTOMER WAS UNRESPONSIVE AND SWEATY AROUND 8:50 AM WHEN DAUGHTER ATTEMPTED TO WAKE CUSTOMER UP TO EAT BREAKFAST ON THE MORNING OF (B)(6) 2013. CALLER REPORTED AN AVIVA BLOOD GLUCOSE RESULT 97 MG/DL WAS OBTAINED AT THAT TIME. THE DAUGHTER CALLED THE EMTS WHO ARRIVED WITHIN 5 MINUTES AND OBTAINED A READING ON THEIR SYSTEM OF 39 MG/DL. EMTS ATTEMPTED TO GIVE THE CUSTOMER GLUCOSE PASTE AND THEN FURTHER TREATED WITH IV OF UNKNOWN CONTENTS. WITHIN 15 MINUTES THE CUSTOMER REGAINED CONSCIOUSNESS. BLOOD GLUCOSE WAS RETESTED AT THAT TIME AND WAS 353 MG/DL ON THE EMT METER AND 157 MG/DL ON THE AVIVA. 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
    200783 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female LANTUS| NEBULIZER| LANTUS| NEBULIZER