BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220079 · Received August 12, 2011

    Report

    Report Number
    2027969-2011-01792
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 25, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS (B)(6). PER PRODUCT USER GUIDE, "TESTING HAS BEEN LIMITED TO SUBJECTS AGE 18 AND OLDER." PT HAS A HISTORY OF THYROID PROBLEMS AND TAKES DIGOXIN AND ATENOLOL. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." PT CURRENT MEDICATION AND HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. PT IS HOLDING FINGER ON GREEN LIGHT UNTIL METER BEEPS. FINGER SHOULD NOT TOUCH THE STRIP WHEN APPLYING SAMPLE. THIS MAY AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR OR ERRORS IN TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011 - 1ST INR = 4.4, 2ND INR = 3.4, 3RD INR = 2.9, MEAN = 3.57, SD = 0.76, %CV = 21.41. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. INR RESULTS FROM (B)(6) 2011 WERE EXCLUDED FROM DATA ANALYSIS BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. RECENT TEST CONDUCTED ON LOT 243104 ON 7/20/2011 MET PRECISION AND ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 74 = 2.1, 1.9, 2.0 INR; DONOR 75 = 3.6, 3.7, 3.7 INR. IN-HOUSE TEST RESULT HAVE 5.0% AND 1.57%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 74 (2.02 INR) AND DONOR 75 (3.48 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: USING INRATIO PRODUCTS FOR PT UNDER 18 WOULD BE CONSIDERED OFF-LABEL USE AS STATED IN PRODUCT PI. PT'S CONDITION MAY ALSO AFFECT TEST RESULT. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET PRECISION CRITERIA. (B)(4). THIS REACHES THE ACTION THRESHOLD OF (B)(4). NOTE BRICK LOT NUMBER 246544 WITH STRIP CODE Z45BU MATERIAL WAS SPLIT INTO TWO DIFFERENT LOTS. LOT# 243104 INTO 12 PACKS (SMALLER LOT). LOT# 251117 INTO 48 PACKS (LARGER LOT). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF (B)(4). CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 4.4, 3.4 AND 2.9. "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 2.0. DATE: (B)(6) 2011, LAB: 2.7. PT IS 16. TECH SUPPORT EXPLAINED THAT METER WAS NOT VALIDATED FOR PTS UNDER 18. MOTHER WAS AWARE OF THIS. THERAPEUTIC RANGE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR