BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1807650 · Received August 13, 2010

    Report

    Report Number
    2027969-2010-01209
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY COMPARISON OF INR VALUES REPORTED BY USER: DATE: (B)(6) 2010, INRATIO: 5.2 INR, REFERENCE: 2.9 INR, MEAN: 4.05, CONFIDENCE LIMITS: 2.3-5.7. DATE: (B)(6) 2010, INRATIO: 3.4 INR, REFERENCE: 2.5 INR, MEAN: 2.95, CONFIDENCE LIMITS: 1.8-4.2. DATE: (B)(6) 2010, INRATIO: 4.9 INR, REFERENCE: 3.0 INR, MEAN: 3.95, CONFIDENCE LIMITS: 2.3-5.7. DATE: (B)(6) 2010, INRATIO: 1.3 INR, REFERENCE: 1.7 INR, MEAN: 1.5, CONFIDENCE LIMITS: 1.1-1.9. THE MEANS OF THE INRATIO METER AND COMPARATIVE SYSTEM INRS WERE CALCULATED. ALL 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. THE REPORTED INR VALUES MEET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION REQUIRED. SUMMARY: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. AS OF 08/11/2010, 9 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #232886 YIELDING A COMPLAINT RATE OF 0.005%. 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION 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) 2010, INRATIO: 5.2, LAB: 2.9. DATE: (B)(6) 2010, INRATIO: 3.4, LAB: 2.5. DATE: (B)(6) 2010, INRATIO: 4.9, LAB: 3.0. DATE: (B)(6) 2010, INRATIO: 1.3, LAB: 1.7. CUSTOMER REPORTED SEVERAL DISCREPANT RESULTS FROM SEVERAL PATIENTS FROM (B)(6) 2010 AND (B)(6) 2010. NO SPECIFIC DETAILS OR PATIENT CONDITIONS PROVIDED. CUSTOMER STATED PATIENTS ARE REGULAR, ROUTINE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232886

    Patients

    Seq Age Sex Outcome Treatment
    1