BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1075767 · Received July 11, 2008

    Report

    Report Number
    2954730-2008-00459
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 11, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491. PT #1 FIRST TEST INR (METER# 074159575) = 1.4 SECOND TEST INR (NEW INRATIO) = 2.0 MEAN = 1.7: SD = 0.42; %CV = 24%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491. PT #2 FIRST TEST INR (METER# 074159575) = 1.8. SECOND TEST INR (NEW INRATIO) = 2.3 MEAN = 2.05; SD - 0.35; %CV = 17%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491. PT #3 FIRST TEST INR (METER# 074159575) = 2.0. SECOND TEST INR (NEW INRATIO) = 2.5 MEAN = 2.25; SD = 0.35; %CV = 15.7%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491 PT #4 FIRST TEST INR (METER# 074159575) = 1.6 SECOND TEST INR (NEW INRATIO) = 2.3 MEAN = 1.95; SD = 0.49; %CV = 25%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491. PT #1 FIRST TEST INR(METER# 071950928) = 1.3 SECOND TEST INR (NEW INRATIO) = 2.0 MEAN = 1.65; SD - 0.49; %CV = 30%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491. PT #2 FIRST TEST INR (METER$ 071950928) = 1.7 SECOND TEST INR (NEW INRATIO) = 2.4 MEAN = 2.05; SD = 0.49; %CV = 24%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070491. PT #3 FIRST TEST INR(METER# 071950928) = 1.5 SECOND TEST INR (NEW INRATIO) = 2.1 MEAN = 1.8; SD = 0.42; %CV = 24%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: PT#1 FIRST TEST INR (METER# 074159575) = 1.4. SECOND TEST INR (NEW INRATIO) = 2.0. PT #2 FIRST TEST INR(METER# 074159575) = 1.8. SECOND TEST INR (NEW INRATIO) = 2.3. PT #3 FIRST TEST INR (METER# 074159575) = 2.0. SECOND TEST INR (NEW INRATIO) = 2.5. PT #4 FIRST TEST INR (METER# 074159575) = 1.6 SECOND TEST INR (NEW INRATIO) = 2.3. PT #1 FIRST TEST INR (METER# 071950928) = 1.3. SECOND TEST INR (NEW INRATIO) = 2.0. PT #2 FIRST TEST INR (METER# 071950928) = 1.7. SECOND TEST INR (NEW INRATIO) = 2.4. PT #3 FIRST TEST INR (METER# 071950928) = 1.5. SECOND TEST INR (NEW INRATIO) = 2.1. PT #4 FIRST TEST INR (METER# 071950928) = 1.6. SECOND TEST INR (NEW INRATIO) = 2.4. PT #5 FIRST TEST INR (METER# 071950928) = 1.4. SECOND TEST INR (NEW INRATIO) = 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTRHOMBIN TIME TEST JPA HEMOSENSE, INC. 0100267 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI