BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2860935 · Received December 6, 2012

    Report

    Report Number
    1823260-2012-06157
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 10, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    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 OF 187 MG/DL AND 78 MG/DL, WITHIN 10 MINUTES. CALLER WAS ABLE TO SELF-TREAT SYMPTOMS OF HYPOGLYCEMIA. CALLER REPORTED A SEPARATE COMPARISON ON THE SAME SYSTEM OF 450 MG/DL AND 187 MG/DL, 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
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491316

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR LANTUS| HUMULIN