BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2121309 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03204
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED SYMPTOMS OF HYPOGLYCEMIA, BLOOD GLUCOSE RESULTS OF 9.2 MMOL/L ON MOBILE SYSTEM, 2.6 MMOL/L ON AVIVA SYSTEM WITHIN 10 MINUTES. CUSTOMER SELF-TREATED WITH FOOD, REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302762

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR UNSPECIFIED HIGH BLOOD PRESSURE MED| UNSPECIFIED ALLERGY MED| UNSPECIFIED CHOLESTEROL MED| ALBYL-E| NOVORAPID 4XDAY| LANTUS 1XDAY