BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4170582 · Received October 14, 2014

    Report

    Report Number
    1823260-2014-07863
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 4, 2014
    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
    NY, 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 319 MG/DL AND 125 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
    651183 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493744

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male ATORVASTATIN| CITALOPRAM| FISH OIL| HUMALOG| HYDROCORTISONE| LANTUS| METOPROLOL| VITAMIN D| METOPROLOL| LANTUS| FISH OIL| HUMALOG| ATORVASTATIN| VITAMIN D| HYDROCORTISONE| CITALOPRAM