BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 1776217 · Received July 29, 2010

    Report

    Report Number
    1823260-2010-04551
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM. REFERENCE MEDWATCH REPORT WITH (B)(4) FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 110 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 207 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT HE USED AN INSULIN FLEX PEN AFTER GETTING THE 207 MG/DL RESULT AND ALSO HIS NORMAL 1000 MG OF METFORMIN AND 30 MG OF ACTOS. 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

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR TWO PATIENT SAMPLES UPON REPEAT, BOTH SAMPLES RESULTED IN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT REPORT ANY PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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 302635

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR CHEMO TREATMENTS| METFORMIN (TWICE DAILY)| INSULIN FLEX PEN| ACTOS (DAILY)