BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5408767 · Received February 3, 2016

    Report

    Report Number
    2027969-2016-00073
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    January 6, 2016
    Report Date
    January 7, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE TESTING ON RETAINED STRIP LOT K372403 MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MET RELEASE SPECIFICATIONS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED OF DISCREPANT INRATIO VALUES EVENT OCCURRED IN (B)(6). PATIENT'S THERAPEUTIC RANGE NOT PROVIDED. EXACT DATE UNKNOWN BUT PRIOR TO 01/06/2016 INRATIO INR = 4.0. (B)(6) 2016 INRATIO INR = >7.5. NO PHENPROCOUMON RECEIVED BETWEEN 4.0 AND >7.5 INR VALUES. (B)(6) 2016 LAB VENOUS DRAW INR = 6.0. ACCORDING TO PATIENT'S PHYSICIAN THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66672 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K372403

    Patients

    Seq Age Sex Outcome Treatment
    1