BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2230938 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01589
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DESCRIPTION, TIME OF TESTING BETWEEN INRATIO RESULTS IS NOT INDICATED. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. CUSTOMER RECENTLY BEGAN TAKING NITRO. 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." INRATIO PRECISION DATE PROVIDED BY END-USER LOT: DATE: UNK, 1ST INR = 1.5, 2ND INR = 1.6, 3RD INR: 1.7, 4TH INR = 3.6, MEAN: 2.1, SD = 1.00, %CV = 47.78, SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT 248203 ON 07/07/2011 MET BOTH PRECISION AND ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 66 = 2.1, 2.3, 2.1 INR; DONOR 67 = 3.4, 3.7, 3.5, INR. IN-HOUSE TEST RESULTS HAVE 5.33% AND 4.32%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 15% CV. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 66. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULTS COMPARISON DID NOT MEET PRECISION CRITERIA. PT'S MEDICATION MAY NOT BE RULED OUT. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO CUSTOMER PROVIDED. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET PRECISION CRITERIA. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. FROM 08/19/2010 TO 07/19/2011, THERE HAVE BEEN THERAPEUTIC AND 13 THERAPEUTIC DONOR SAMPLE TESTS WITH 88 STRIPS PERFORMED. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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: DATE: "WEEKS AGO, INRATIO: 3.6, UNK: 1.5, UNK: 1.6, UNK: 1.7. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. PT SELF TESTER STATES THAT HIS INR HAS BEEN CONSISTENTLY IN THE MID ONES OVER THE PAST FEW WEEKS EXCEPT FOR ONE RESULT OF 3.6 "A FEW WEEKS AGO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1