BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 5723705 · Received June 14, 2016

    Report

    Report Number
    3011393376-2016-03861
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    April 22, 2016
    Report Date
    July 24, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ERRORS THAT OCCURRED IN THE SUBMISSION OF MDRS FOR INCORRECT MANUFACTURER NAME AND/OR ADDRESS. A NON-CONFORMANCE REPORT (NCR) ¿ (B)(4) TO IMPLEMENT CORRECTIVE ACTIONS WAS OPENED ON JANUARY 29, 2025. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    VA NURSE CALLED TO REPORT THE FOLLOWING READINGS WERE ON THE CUSTOMER'S METER: (B)(6) 2016 - 17 MG/DL AND 113 MG/DL WITHIN 10 MINUTES. (B)(6) 2016 - 25 MG/DL AND 109 MG/DL WITHIN 10 MINUTES. (B)(6) 2016 - 19 MG/DL AND 111 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT REPORTED, METER AND STRIPS REPLACED AND REQUESTED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378056 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male