BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3725079 · Received April 3, 2014

    Report

    Report Number
    1823260-2014-02368
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    July 12, 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
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE METER IN (B)(4) IS THE SAME AS IN (B)(4). WHEN THE CUSTOMER RETURNED HIS METER AS REQUESTED IN (B)(4), THE ATTACHED LETTER, FROM WHICH (B)(4) WAS CREATED, WAS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS, ALL MG/DL: (B)(6) 2013; 08:26 AM 22; (B)(6) 2013 08:27 AM 82; (B)(6) 2013 08:44 AM 34; (B)(6) 2013 08:45 AM 98; (B)(6) 2013 08:44 AM 24; (B)(6) 2013 08:45 AM 80; (B)(6) 2013 12:05 AM 44; (B)(6) 2013 12:07 AM 173. NO ADVERSE EVENT WAS REPORTED. THE STRIPS ARE NOT EXPECTED TO BE RETURNED, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202608 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male