BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1844082 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05691
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE : (B)(6) 2010, INRATIO: NG, LAB: 13.0, PT: 50. DATE: (B)(6) 2010, INRATIO: 4.8, LAB: 10.3. PT WAS GIVEN 3 DOSES OF VITAMIN K DUE TO A LAB READING RECEIVED ON (B)(6) 2010. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. PT'S COUMADIN WAS DECREASED FROM 7 MG TO 6 MG ON (B)(6) 2010.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 159 MG/DL ON ADVANTAGE SYSTEM AND 85 MG/DL ON PROFESSIONAL SYSTEM WITHIN 1 MINUTE. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT SENT.

    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 551080

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR UNKNOWN PILL FOR CHOLESTEROL| UNKNOWN PILL FOR DIABETES| CALCIUM PILL 1XDAY| UNKNOWN PILL FOR BLOOD PRESSURE| VITAMIN-CENTRIUM 1XDAY