BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2243704 · Received July 28, 2011

    Report

    Report Number
    2027969-2011-01667
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 28, 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
    NM, 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: 6.2, REFERENCE: 3.9, MEAN: 5.05, CONFIDENCE LIMITS: NA. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 5.2, 2ND INR: 7.2, 3RD INR: 6.2, MEAN: 6.20, SD: 1.00, %CV: 16.13. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. HOWEVER, REPEATED INRATIO TEST RESULT COMPARISON DID MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON 07/20/2011 REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT # 243934. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ALLOWABLE ACCURACY BIAS (+ OF - 1.0). NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). ACTION THRESHOLD (B)(4) WAS REACHED. FROM 08/19/2010 TO 07/28/2011, SEVENTEEN THERAPEUTIC DONOR SAMPLE TESTS HAVE BEEN PERFORMED. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (PT'S CAREGIVER, SON) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 6.2, LAB: 3.9. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 5.2, 7.2, 6.2. 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