BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1791980 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04728
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    April 23, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR ONE OF THE SUSPECT DEVICES USED, AS THE CUSTOMER COULD NOT BE SURE WHICH RESULT WAS OBTAINED ON WHICH DEVICE. REFERENCE MEDWATCH REPORT WITH (B)(4) FOR THE OTHER SUSPECT DEVICE USED.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A RESULT OF 100 MG/DL ON AVIVA SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 30 MG/DL ON AVIVA SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THE CUSTOMER WAS FEELING VERY SHAKY, OUT OF IT, VERY SWEATY AND DIZZY SO SHE HAD TO TREAT HIM WITH GLUCOSE, FOOD, AND JUICE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, SMOKE REEKED UP AND THE TISSUE PAD WAS DETACHED OFF. AS THE TISSUE PAD WAS RETRIEVED, NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 301785

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR