BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1852456 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05871
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE AVIVA SYSTEM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 339 MG/DL (COMPACT PLUS) AND 150 MG/DL (AVIVA). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A DAMAGED DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    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 302594

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR DIAZEPAM| CALCIUM PLUS D| CLONIDINE| METFORMIN| FUROSEMIDE| CENTRUM SILVER| ANTACAND| ZOCOR| POTASSIUM| SYNTHROID| ASPIRIN| AEROSOL INHALER