BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220055 · Received August 12, 2011

    Report

    Report Number
    2027969-2011-01796
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 15, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INR RESULT OBTAINED IN LN 243103 WAS EXCLUDED FROM DATA ANALYSIS BECAUSE CUSTOMER DID NOT HAVE CORRECT STRIP CODE IN METER. THIS WOULD CAUSE THE RESULTS OBTAINED TO BE INVALID. RESULT FROM LN 243104 WAS ANALYZED FOR ANOTHER COMPLAINT AND WILL BE INCLUDED ON ANOTHER MEDWATCH REPORT. RECENT TEST CONDUCTED ON LOT 243103 ON 7/20/2011 MET PRECISION AND ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 74 = 2.2, 2.1, 2.1 INR; DONOR 75 = 3.7, 3.8, 4.0 INR. IN-HOUSE TEST RESULTS HAVE 2.71% AND 3.98%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+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. (B)(4). THIS REACHES THE ACTION THRESHOLD OF (B)(4). NOTE BRICK LOT NUMBER 237417 HAS STRIP CODE 9075R MATERIAL WAS SPLIT INTO TWO DIFFERENT LOTS: LOT # 243103 INTO 12 PACKS (SMALLER LOT), LOT# 246450 INFO 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 DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011; INRATIO: 6.5 LOT NUMBER 243103, 5.3 LOT NUMBER 243104; LAB: 4.4. CUSTOMER TESTED WITH THE WRONG STRIP CODE AND RECEIVED A 6.5, ABOUT 17 MINUTES LATER HE TESTED THE SAME FINGER WITH THE CORRECT STRIP CODE AND RECEIVED A 5.3 ON HIS METER. TWENTY MINUTES LATER, HE RECEIVED A 4.4 LAB RESULT. DOSAGE OF COUMADIN HAS BEEN GETTING CHANGED AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1