BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3870221 · Received June 12, 2014

    Report

    Report Number
    1823260-2014-04308
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 26, 2014
    Report Date
    August 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF "HI" (>600 MG/DL) AND 260 MG/DL WITHIN 1 MINUTE ON THE AVIVA COMBO SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED IN RELATION TO THIS COMPLAINT. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347650 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492216

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male ALEVE| APIDRA| CLONAZEPAM| COZAR| LEXIPRO| MAGNISIUM| MELATONIN| PRILOSEC| SYNTHROID| TRAZODONE| VITAMIN D| VYVANSE| WELBUTRIN| VITAMIN D| MELATONIN| MAGNISIUM| SYNTHROID| PRILOSEC| COZAR| VYVANSE| CLONAZEPAM| ALEVE| APIDRA| LEXIPRO| WELBUTRIN| TRAZODONE