BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3083043 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02616
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 1. 314 MG/DL AND 138 MG/DL 2. 109 MG/DL, 172 MG/DL, 192 MG/DL, 402 MG/DL, 215 MG/DL, 367 MG/DL, 174 MG/DL, HI (GREATER THAN 600 MG/DL), AND 121 MG/DL 3. 197 MG/DL AND 432 MG/DL 4. 63 MG/DL AND 197 MG/DL SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185086 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303502

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male GLUCOSE TABLET| GLYBURIDE| LISINOPRIL| LISINOPRIL HCTZ| METFORMIN| METFORMIN| GLYBURIDE| LISINOPRIL HCTZ| LISINOPRIL| GLUCOSE TABLET