BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO

    MDR report key: 2042193 · Received March 25, 2011

    Report

    Report Number
    2027969-2011-00614
    Event Type
    Death
    Date Received
    March 25, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.1, REFERENCE: 3.4, MEAN: 2.75, CONFIDENCE LIMITS: 1.7-3.8. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. ADD'L RETAINED TESTING PERFORMED ON (B)(4) 2011 ALSO REVEALED THAT ACCURACY CRITERIA WAS MET. PER GENERAL DESCRIPTION OF COMPLAINT, PT HAD SEVERE HEART FAILURE AND WAS TAKING A LOT OF MEDICATIONS. CALLER REPORTED THAT DEATH OF PT WAS NOT DUE TO HIS INR OR INR READINGS. PT'S HEALTH CONDITION AT THE TIME OF COAGULATION TESTING MAY HAVE CONTRIBUTED TO UNEXPECTED INRATIO RESULT. AS REVIEWED ON (B)(4) 2011, TWENTY-NINE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #239277, YIELDING A COMPLAINT RATE OF 0.007%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), 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. ADD'L INVESTIGATION RESULTS ON RETAINED STRIP LOT #239277: DONOR 2, INRATIO: 1.6, INRATIO: 1.6, INRATIO: 1.6, REFERENCE: 1.55, RESOLUTION: PASS. DONOR 3, INRATIO: 2.7, INRATIO: 2.4, INRATIO: 2.5, REFERENCE: 2.45, RESOLUTION: PASS. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS OF THE REFERENCE RESULTS FOR DONOR 2 (1.55 INR) AND DONOR 3 (2.45 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 2.1, LAB: 3.4. PT PASSED AWAY ON (B)(6) 2011 DUE TO HEART FAILURE. CALLER SPECIFIED THAT THE DEATH HAD NOTHING TO DO WITH HIS INR OR INR READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 239277

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death