BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3961727 · Received July 28, 2014

    Report

    Report Number
    1823260-2014-05597
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 2, 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
    SC, 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, ALL MG/DL: 8:17PM (B)(6) 2014, 202 8:18PM (B)(6) 2014, 109 8:20PM (B)(6) 2014, 116 8:21PM (B)(6) 2014, 157 8:22PM (B)(6) 2014, 100 8:23PM (B)(6) 2014, 94 8:25PM (B)(6) 2014, 89 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
    439350 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493685

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female PRENATE ELITE| PRENATE ELITE