BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3102993 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02843
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 13, 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
    TX, 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.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 72 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
    203712 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491394

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male AGGRENOX 2X PER DAY| ASPIRIN 1X A DAY| CARVEDILOL 2 X DAY| INSULIN PEN (LEVEMIR)| INSULIN PEN (NOVOLOG)| LEVEMIR| LEVOTHYROXINE 1X PER DAY| NITROGLYCERIN| NOVOLOG| OMEPRAZOLE 1X PER DAY| PLAVIX 1X A DAY| SYRINGE (VITAMIN B)| TRICOR 1X PER DAY| VITAMIN B INJECTION 1X MONTH| VITAMIN B INJECTION 1X MONTH| OMEPRAZOLE 1X PER DAY| NITROGLYCERIN| NOVOLOG| LEVEMIR| TRICOR 1X PER DAY| CARVEDILOL 2 X DAY| SYRINGE (VITAMIN B)| AGGRENOX 2X PER DAY| ASPIRIN 1X A DAY| PLAVIX 1X A DAY| LEVOTHYROXINE 1X PER DAY| INSULIN PEN (NOVOLOG)| INSULIN PEN (LEVEMIR)