BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2091485 · Received May 6, 2011

    Report

    Report Number
    2027969-2011-01003
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAS HYPOTHYROIDISM AND A BLADDER INFECTION. CURRENT MEDICATIONS INCLUDE TAKING ANTIBIOTICS, 81 MG ASPIRIN, LANTIS, METFORMIN, SIMVASTATIN, LEVOTHYROXINE (FOR HYPOTHYROIDISM), SOTALOL (A FIB), AND LOSARTIN. 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 AFFECT COAGULATION TEST. THIS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. CUSTOMER SOMETIMES APPLIES MULTIPLE DROPS OF BLOOD. THIS PRE-ANALYTICAL TECHNIQUES MAY CONTRIBUTE TO INACCURATE INR RESULT OR TESTING ERROR. BE ADVISED TO APPLY A SINGLE HANGING DROP OF BLOOD ON SAMPLE WELL. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST INR = 7.1, 2ND INR = 1.6, 3RD INR = 6.6, MEAN: 5.10, SD: 3.04, %CV: 59.63. SINCE %CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT# 241836 MET PRECISION CRITERIA. DATE: (B)(6) 2011, DONOR 1: 1ST INR: 3.0, 2ND INR: 3.0, 3RD INR: 3.0, MEAN: 3.0, SD: 0.00, %CV: 0.00. DONOR 2: 1ST INR: 2.7, 2ND INR: 2.3, 3RD INR: 2.6, MEAN: 2.53, SD: 0.21, %CV: 8.22. SINCE %CV IS LESS THAN 16%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. CUSTOMER FOLLOW UP INDICATES CUSTOMER IS SATISFIED WITH METER AND LAB CORRELATION. CONCLUSION: 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. AS REVIEWED ON (B)(6) 2011, (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT# 241836 YIELDING A COMPLAINT RATE OF (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. SINCE STRIP LOT WAS RELEASED, 6 IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE REQUIREMENTS WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WIL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 7.1, RE-TEST: 1.6, RE-TEST: 6.6. DATE: (B)(6) 2011, INRATIO: 2.0. PT SELF TESTER HAD A BLADDER INFECTION; WENT TO THE DOCTOR ON (B)(6) 2011 AND THE DOCTOR SAID, SHE HAD BLOOD IN THE URINE. PT WAS GIVEN ANTIBIOTICS, BUT RAN OUT ON (B)(6) 2011. GOT A NEW PRESCRIPTION FOR ANTIBIOTICS BUT HAD NOT YET FILLED IT. PT NOTICED BLOOD IN HER URINE SINCE THE DOCTOR VISIT. PT CALLED THE RESULT IN TO THE DOCTOR AND THEY ADVISED HOLDING COUMADIN DOSE FOR 3 DAYS. PT REPORTS SOMETIMES APPLYING MULTIPLE DROPS OF BLOOD TO THE STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other