BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3112453 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02952
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 17, 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
    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 266 MG/DL, 144 MG/DL, AND 96 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
    211992 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ASPIRIN 1X A DAY| DIGOXIN 1XDAY| EXFORGE 1XDAY| GLIMEPIRIDE 2XDAY| HYDROCHLORIDE 1XDAY| LANTUS| MULTAQ 2XDAY| NOVOLOG 70/30| PLAVIX 1X A DAY| SIMVASTATIN 1XDAY| SYNTHROID 1XDAY| TOPROL XL 1XDAY| TRICOR 1X PER DAY| VESICARE 1XDAY| ASPIRIN 1X A DAY| GLIMEPIRIDE 2XDAY| SIMVASTATIN 1XDAY| PLAVIX 1X A DAY| DIGOXIN 1XDAY| SYNTHROID 1XDAY| NOVOLOG 70/30| LANTUS| HYDROCHLORIDE 1XDAY| VESICARE 1XDAY| MULTAQ 2XDAY| TRICOR 1X PER DAY| TOPROL XL 1XDAY| EXFORGE 1XDAY