BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2981372 · Received February 27, 2013

    Report

    Report Number
    1823260-2013-01199
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 22, 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
    GA, 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 HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, 266 MG/DL, 432 MG/DL, 167 MG/DL, AND 233 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
    85054 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491375

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female BAYER ASPIRIN| CLONIDINE| CYCLOBENZAPRINE| D3 SUPPLEMENT| DIGOXIN| HYDROXYZINE| LEXAPRO| METFORMIN| METOPROLOL| NEXIUM| SUPER B VITAMIN COMPLEX| SYNTHROID| ZETIA| SUPER B VITAMIN COMPLEX| BAYER ASPIRIN| NEXIUM| METFORMIN| METOPROLOL| DIGOXIN| CYCLOBENZAPRINE| HYDROXYZINE| SYNTHROID| LEXAPRO| ZETIA| CLONIDINE| D3 SUPPLEMENT