BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3130046 · Received May 24, 2013

    Report

    Report Number
    1823260-2013-03187
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 1, 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
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR NANO SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR AVIVA SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 502 MG/DL AND 202 MG/DL ON AVIVA SYSTEM, 202 MG/DL ON THE NANO SYSTEM WITHIN 10 MINUTES. 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
    231283 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491335

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male ACCUCHEK COMBO SYSTEM| ALLOPURINOL| ANGOGRO GEL(STEROID)| ASPIRIN| BETANECOL| FASTCLIX| HUMALOG U100| LOVASTATIN| MULTI - VITAMIN| MYCOPHENOLATE| NANO METER| PREDNISONE| PROSTATITIS LEG| RANITIDINE| TACROLIMUS| VITD (VITAMIN D)| LOVASTATIN| ALLOPURINOL| FASTCLIX| ASPIRIN| PREDNISONE| TACROLIMUS| MYCOPHENOLATE| HUMALOG U100| NANO METER| VITD (VITAMIN D)| MULTI - VITAMIN| RANITIDINE| BETANECOL| ANGOGRO GEL(STEROID)| ACCUCHEK COMBO SYSTEM| PROSTATITIS LEG