BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3863851 · Received June 10, 2014

    Report

    Report Number
    1823260-2014-04215
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 22, 2014
    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
    ME, US
    Reporter Occupation
    OTHER
    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

    THE CUSTOMER EXPERIENCED HYPOGLYCEMIC SYMPTOMS OF SWEATING, DISORIENTATION, AND SLURRED SPEECH AT 3:30 A.M. HIS FIANCÉ TESTED HIS BLOOD GLUCOSE, AND THE RESULT WAS 82 MG/DL. SHE CONTACTED THE PARAMEDICS, AND THEY ARRIVED WITHIN 10 MINUTES. HIS BLOOD GLUCOSE WAS TESTED ON THE PARAMEDICS MONITOR, AND THE RESULT WAS 58 MG/DL. HE WAS NOT CAPABLE OF SELF-TREATMENT AND WAS GIVEN 6-8 OUNCES OF ORANGE JUICE, 1/2 SLICE OF TOAST WITH PEANUT BUTTER, AND A PEANUT BUTTER BAR. THE CUSTOMER HAD TAKEN HIS NORMAL MEDICATION PRIOR TO THE INCIDENT. THE ALLEGED PRODUCTS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339234 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491839

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male HUMULIN R| LANTUS| HUMULIN R| LANTUS