BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4090096 · Received September 15, 2014

    Report

    Report Number
    1823260-2014-07013
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    March 3, 2014
    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
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. CHANGED INFORMATION TO ASKU. THE STRIP LOT USED WAS NOT KNOWN AND WAS INCORRECTLY REPORTED AS THE LOT RETURNED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. CUSTOMER NO LONGER HAS TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 990 MG/DL, 800 MG/DL, 500 MG/DL, AND 200 MG/DL. CUSTOMER WAS NAUSEATED, DIZZY, AND SWEATY. NO ACTION TAKEN BASED UPON READINGS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS,HOWEVER, STRIPS ARE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570130 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493562

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male ALLOPURINOL| GLIPIZIDE| LISINOPRIL| METFORMIN| OMEPRAZOLE| SIMVASTATIN| OMEPRAZOLE| METFORMIN| ALLOPURINOL| LISINOPRIL| GLIPIZIDE| SIMVASTATIN