BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4110277 · Received September 12, 2014

    Report

    Report Number
    2027969-2014-00839
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. SINCE THE PRODUCT IS NOT RETURNING FOR EVAL. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. A REVIEW OF THE MFR RECORD FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCE. LOT MEETS RELEASE SPECIFICATION. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6). INRATIO: 3.8. A 1ST RE-TEST: GREATER THAN 7.5. A 2ND RE-TEST: 5.6. DATE: (B)(6). INRATIO: 2.7. A 1ST RE-TEST: 5.5. A 2ND RE-TEST: GREATER THAN 7.5. MD LAB: 2.7. TIME BETWEEN TESTS: INRATIO TESTS ON (B)(6) WERE ALL PERFORMED WITHIN 9 MINUTES. A 16 HOURS BETWEEN INRATIO TESTS ON (B)(6) AND INRATIO 2.7 INR ON (B)(6). A 6.5 HOURS BETWEEN INRATIO 2.7 INR ON (B)(6) AND MD LAB. LESS THAN 1 HOUR BETWEEN MD LAB ON (B)(6) AND INRATIO TESTS (5.5 AND GREATER THAN 7.5). LESS THAN 5 MINUTES BETWEEN THE INRATIO TESTS THAT WERE PERFORMED AFTER THE MD LAB DRAW ON (B)(6) (5.5 AND GREATER THAN 7.5 INR). THERAPEUTIC RANGE: 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566659 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 335798

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SERIAL NUMBER: (B)(4)| WARFARIN