BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2000618 · Received February 24, 2011

    Report

    Report Number
    1823260-2011-01025
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 202942, EXPIRATION DATE 03/31/2012). REFERENCE MEDWATCH REPORT WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 14.2 MMOL/L ON AVIVA SYSTEM 1 AND 7.3 MMOL/L ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    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 202942

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR UNKNOWN BLOOD PRESSURE MED| UNKNOWN "BLADDER" MED| HUMULIN N| ASA| UNKNOWN "STOMACH" MED| UNKNOWN MED FOR MUSCLE CRAMP| RAMIPRIL