BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2372251 · Received November 28, 2011

    Report

    Report Number
    2027969-2011-02419
    Event Type
    Malfunction
    Date Received
    November 28, 2011
    Date of Event
    October 31, 2011
    Report Date
    November 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO2 PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.4, 2ND INR: 0.9, MEAN: 1.15, SD: 0.35, %CV: 30.74. CALLER ALSO REPORTED A "HI" RESULT, WHICH MAY BE ATTRIBUTED TO A QC ERROR. QC ERRORS ARE DESIGNED TO BE GENERATED WHEN THE QUALITY OF THE RESULTS, AS RELATED TO THE QC RESULT, HAS BEEN COMPROMISED. THIS CAN BE CAUSED BY A NUMBER OF FACTORS, INCLUDING ENVIRONMENTAL FACTORS, SAMPLING TECHNIQUE, AND/OR ENDOGENOUS FACTORS. THERE WERE NO INDICATIONS OF SAMPLING OR TECHNIQUE PROBLEMS. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO2 TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON 10/26/2011 REVEALED THAT RESULTS COMPARISONS MET PRECISION CRITERIA. (SEE BELOW). INVESTIGATION RESULTS FOR RETAINED STRIPS LOT# 253025: DONOR: 121, 1ST INR: 3.4, 2ND INR: 3.3, 3RD INR: 3.3, MEAN: 3.33, SD: 0.06, %CV: 1.73. DONOR: 122, 4.0, 3.8, 3.9, 3.90, 0.10, 2.56. %CV FOR BOTH DONORS ARE LESS THAN 16% AND MEET THE CRITERIA FOR PRECISION. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (NURSE) ALLEGED IMPRECISION WITH INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 1.4, "HI", 0.9. NURSE HAD NO INFO ON THE PT OR THE PROCEDURE USED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253025

    Patients

    Seq Age Sex Outcome Treatment
    1 NI