BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2192687 · Received August 5, 2011

    Report

    Report Number
    1823260-2011-04216
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM (LOT NUMBER 303140, EXPIRATION DATE 10/31/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 52 MG/DL ON THE AVIVA SYSTEM AND RESULT OF 102 MG/DL ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS WITHIN 10 MINUTES. CUSTOMER DRANK SWEETENED CRANBERRY JUICE BASED ON RESULT OF 52 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 303140

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR SYNTHROID| LANTUS| ZYRTEC| HUMALOG PEN AS NEEDED