BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 828945 · Received February 9, 2007

    Report

    Report Number
    2954730-2007-00080
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 9, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060541: 2007, PT#1, FIRST TEST INR = 5.0; SECOND TEST INR = 0.7. MEAN = 2.85; SD = 3.04; %CV = 106%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060541: 2007, PT#2; FIRST TEST INR = 7.3; SECOND TEST INR = 4.8. MEAN = 6.05; SD = 1.76; %CV = 29%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: SEE SCANNED TABLE. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE PT#1 SECOND SET OF DATA, BOTH LAB AND INR VALUES WERE OUTSIDE CONFIDENCE LIMIT. PRODUCTS WILL BE TESTED. FOR THE PT#2, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. FOR THE PT#2 FIRST SET OF DATA, BOTH LAB AND INR VALUES WERE > 5.0. THE COMPARISON WAS NOT CONSIDERED INACCURATE. FOR THE PT#2 SECOND SET OF DATA, THE MEAN WAS > 5.0 AND THE DIFFERENCE BETWEEN INR'S WAS > 2.2. THE COMPARISON WAS CONSIDERED INACCURATE. PRODUCTS WILL BE TESTED. PER TEST "THE SECOND PATIENT HAD JUST RETURNED FROM DIALYSIS AND WAS GIVEN HEPARIN." HEPARIN MAY CAUSED THE DISCREPANCY BETWEEN INRATIO AND LAB VALUES.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: 2007, PT#1, FIRST TEST INR = 5.0; SECOND TEST INR = 0.7. 2007, PT#2, FIRST TEST INR = 7.3; SECOND TEST INR = 4.8. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: SEE SCANNED TABLE. PER TEXT "THE SECOND PATIENT HAD JUST RETURNED FROM DIALYSIS AND WAS GIVEN HEPARIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060541

    Patients

    Seq Age Sex Outcome Treatment
    1 *