BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2254898 · Received September 13, 2011

    Report

    Report Number
    2027969-2011-01952
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS USING UNKNOWN GAUGE LANCET, WHICH MAY AFFECT OBTAINING THE CORRECT SAMPLE SIZE FOR TESTING. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.3, REFERENCE: 2.64, MEAN: 1.97, CONFIDENCE LIMITS: 1.3 - 2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO FURTHER INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT NUMBER 253026 ON (B)(6) 2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 88 = 4.1, 4.0, 4.5 INR; DONOR 89= 3.0, 114 (ERROR), 3.8 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 88 (3.43 INR) AND DONOR 89 (3.02 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CUSTOMER REPORTED SMALL SAMPLE SIZE IN INRATIO TEST RESULT. CUSTOMER'S LANCET SIZE WAS UNKNOWN. ANALYSIS OF CLIENT'S DATA FROM INRATIO AND REFERENCE TEST REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. AS REVIEWED ON (B)(6) 2011, 26 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT NUMBER 253026 YIELDING A COMPLAINT RATE OF 0.006 PERCENT DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07 PERCENT) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: PATIENT ONE: DATE: (B)(6) 2011, INRATIO: 1.3, LAB: 2.64. LESS THAN 1 HOUR BETWEEN METER TEST AND LAB DRAW. NURSE WHO PERFORMED TEST SAID THE BLOOD DROP SAMPLE WAS RATHER SMALL. HEMATOCRIT IS 39 PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1