BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2110487 · Received April 25, 2011

    Report

    Report Number
    2027969-2011-00916
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON CUSTOMER'S RESULTS SINCE INRATIO AND REFERENCE TESTS WERE DONE FOUR HOURS APART. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT TEST RESULT COMPARISONS MET ACCURACY CRITERIA. AS OF 4/25/2011, (B)(4) COMPLAINTS HAVE BEEN REPORTED FOR LOT #243934. THIS REACHES THE ACTION THRESHOLD. BRICK LOT NUMBER 233254 HAS STRIP CODE (B)(4), MATERIAL WAS SPLIT INTO TWO DIFFERENT LOTS: LOT #243934 INTO 12 PACKS (SMALLER LOT) AND LOT #241836 INTO 12 PACKS (LARGER LOT). THEREFORE, (B)(4) COMPLAINTS HAVE BEEN REPORTED FOR LOT NUMBERS 243934 AND 241836. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD ((B)(4)), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. (B)(4) 2010 TO (B)(4) 2011, 9 THERAPEUTIC AND 3 NORMAL DONOR SAMPLE TESTS HAVE BEEN PERFORMED. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST 2 OUT OF 3 REPLICATES FOR BOTH SAMPLES TESTED ON STRIP LOT #243934 ARE WITHIN THE ALLOWABLE BIAS (+ OR -1.0). NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.4, LAB: 1.8. PT'S THERAPEUTIC RANGE: 2.0 - 3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI