BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3232144 · Received July 17, 2013

    Report

    Report Number
    1823260-2013-04308
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 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
    MD, 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, ALL MG/DL: 10:34 AM - 96, 10:29 AM - 206. CUSTOMER HAD PREVIOUSLY TESTED YESTERDAY NIGHT ON (B)(6) 2013 AND GOT A 117 WHICH WAS PRETTY NORMAL FOR HER. CUSTOMER STATED SHE TOOK 1000 MG METFORMIN THIS MORNING AT 7 AM WITH HER BREAKFAST. CUSTOMER STATED WAS FEELING A BIT DIZZY AND TESTED HER SUGAR WHICH SHOWED 206. CUSTOMER THEN DECIDED TO TAKE ANOTHER 1000 MG OF METFORMIN. THE CUSTOMER STATED SHE THEN TESTED AGAIN AND THAT IS WHEN SHE GOT THE 96. CUSTOMER THEN GOT SOME CANDY IN ORDER TO TREAT FOR LOW BLOOD. CUSTOMER STATED WAS FEELING WELL WHILE ON THE PHONE. CUSTOMER TESTED WHILE ON THE PHONE AND GOT AN 88 AROUND 11:15 AM. 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
    331530 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491399

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female CRESTOR| LEXAPRO - GENERIC| METFORMIN| NEXIUM| PREMPRO| TRICOR - GENERIC 1 X DAY| METFORMIN| PREMPRO| LEXAPRO - GENERIC| TRICOR - GENERIC 1 X DAY| CRESTOR| NEXIUM