BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1397612 · Received April 2, 2009

    Report

    Report Number
    2027969-2009-00176
    Event Type
    Malfunction
    Date Received
    April 2, 2009
    Date of Event
    March 9, 2009
    Report Date
    April 1, 2009
    Manufacturer
    BIOSITE INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: 2009, 1ST INR = 1.6 AND 2ND INR = 2.5. INRATIO METER: MEAN: 2.1, SD: 0.6, %CV: 31.0. THE 31.0% IS MORE THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL PRECISION INVESTIGATION WAS PERFORMED. IN-HOUSE PRECISION TEST FOR 080584A. INRATIO METER: IN-HOUSE METERS. RETAINED STRIP: 080584A. TWO THERAPEUTIC DONORS. IN-HOUSE PRECISION FOR 070743A. INRATIO METER: IN-HOUSE METERS, RETAINED STRIP: 070743A, TWO THERAPEUTIC DONORS. RESULTS OF IN-HOUSE PRECISION TESTING PROVIDED (INRATIO METER): DONOR 1, INR: 2.0, INR: 2.5, MEAN: 2.25, SD: 0.35, %CV: 15.71%, PASS. DONOR 2, 2.5, 2.5, 2.50, 0, 0%, PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON EACH STRIP LOT, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. BOTH TESTS, WHICH HAVE 15.71% CV AND 0% CV FOR EACH DONOR, ARE LESS THAN 16%. HENCE, BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO FURTHER ACTION IS REQUIRED. IN-HOUSE PRECISION TESTING PROVIDED (INRATIO METER): DONOR 1, INR: 2.0, INR: 2.7, MEAN: 2.70, SD: 0.00, %CV: 0%, PASS. DONOR 2, 1.9, 1.9, 1.90, 0.00, 0%, PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON EACH STRIP LOT, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. BOTH TESTS, WHICH HAVE 0% CV AND 0% CV FOR EACH DONOR, ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO FURTHER ACTION IS REQUIRED. DEVICE WAS NOT RETURNED FOR EVAL. INVESTIGATION IS CLOSED. AS OF 03/18/2009, THERE HAVE BEEN 15 DISCREPANT RESULTS COMPLAINT REPORTED FOR LOT# 080584 YIELDING A COMPLAINT RATE OF 0.004%. DUE TO THIS LOW OCCURRENCE RATE, IT IS BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION IS REQUIRED, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED DISCREPANT RESULTS BETWEEN TWO INRATIO METERS. CALLER STATED THAT A PT HAD BEEN TESTED AT SISTER SITE ONE-HOUR PREVIOUSLY WITH RESULT OF 1.6. PT DID NOT INFORM OFFICE THAT THEY HAD ALREADY BEEN TESTED, SO PT WAS TESTED AGAIN WITH RESULT OF 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INC. 0100139

    Patients

    Seq Age Sex Outcome Treatment
    1 NI