BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1885232 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06406
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 23, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED FOR HEMOSTASIS IN THE GASTROINTESTINAL TRACT. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEEDLE OF THE INJECTION GOLD PROBE DEVICE OUT OF THE CATHETER TO INJECT ADRENALINE TO STOP THE BLEEDING, BUT THE NEEDLE WOULD NOT COME OUT OF THE CATHETER. WHEN THE NURSE TOOK THE DEVICE OUT OF THE SCOPE, IT SEEMED THE NEEDLE HAD PERFORATED THE CATHETER SHEATH, AND HAD COME OUT THE SIDE OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 96 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 253 MG/DL ON A PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 302616

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR METFORMIN| PREDNISONE| GEMFIBROZIL| GLIPIZIDE