BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2228344 · Received August 24, 2011

    Report

    Report Number
    2027969-2011-01880
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 5, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2011, 1ST INR = 4.7, 2ND INR = 7.2, MEAN = 5.95, SD = 1.77, %CV = 29.71. SINCE % CV IS MORE THAN 20%, THE TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. TYPE OF DONORS: THERAPEUTIC. FUNCTIONAL TEST: NO. VISUAL INSPECTION: YES. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 243394, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 3.45% AND 0%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED. INVESTIGATION CONCLUSION: FOLLOW-UP ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS (INRATIO INR=4.7 AND 7.2) REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION CUSTOMER PROVIDED. RETURNED METER WITH RETAINED STRIPS FROM BOTH LOTS IN COMPLAINT TESTS MET ACCURACY CRITERIA. RETURNED METER FUNCTIONAL TEST RESULT REVEALED NO PRODUCT DEFICIENCY. STRIP CODE TS4XB WAS FOUND IN METER'S MEMORY WHICH BRICK LOT NUMBER 246550 WAS ASSIGNED AND PACKAGED INTO STRIP LOTS (243394 253028 253024). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4). CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) , #(B)(4) INRATIO: 7.2, #(B)(4) INRATIO: 4.7. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. PATIENT COMPARED OLD METER (B)(4) TO NEW REPLACEMENT METER (B)(4). PATIENT RETURNED OLD METER (B)(4), WHICH WAS REPORTED ON MDR #2027969-2011-01385. THIS DATA WAS ORIGINALLY REPORTED ON MDR# 2027969-2011-01385, BUT PATIENT LATER CALLED BACK ON (B)(6) 2011 AND CLARIFIED THAT A DIFFERENT LOT NUMBER (#243394) HAD BEEN USED FOR THE COMPARISON, SO A NEW AND SEPARATE REPORT IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243394

    Patients

    Seq Age Sex Outcome Treatment
    1