BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1842973 · Received September 23, 2010

    Report

    Report Number
    1823260-2010-05660
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DISCREPANCY IN A LAB COMPARISON WITH A DIFFERENT METER, DOCTOR ORDERED THAT ALL FINGER STICK TESTS BE RUN ALONG WITH A LAB. CALLER FROM INFORM SYSTEM USER FACILITY REPORTED PATIENT BLOOD GLUCOSE RESULTS: ON 9/8 AT 5:51, METER RESULT 305 MG/DL, LAB 116 MG/DL. THE SAME METER WAS USED AT 16:10, RESULT 280 MG/DL, LAB WAS 163 MG/DL. CONTROLS WERE RUN ON THIS METER AND PASSED. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT BASED ON THE METER RESULTS. THEY ARE NO LONGER TESTING THIS PATIENT USING FINGER STICKS AND NO TREATMENT WAS GIVEN BASED ON METER READINGS. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK FROM THE CAP PIERCER AT THE WASTE LINE ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551315

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR PRAVASTATIN| HEPARIN| FOLIC ACID| XOPENEX| ATROVENT| NORVASC| PEPCID| DIGOXIN| COLACE| TERAZOSIN HCL| ASPIRIN| CALCIUM POLYCARBOPHIL| SOTALOL HCL| ASPART| CLONIDINE