BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5629235 · Received May 3, 2016

    Report

    Report Number
    2027969-2016-00295
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 23, 2016
    Report Date
    April 4, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, IN-HOUSE RETAIN TESTING 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE LOT NUMBER REFERENCED (K372403) WAS INCORRECT. THIS PARAGRAPH SHOULD HAVE READ AS FOLLOWS; IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, IN-HOUSE RETAIN TESTING WAS PERFORMED IN-HOUSE TESTING ON RETAINED STRIP LOT 382952 MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED.

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE INVESTIGATION. THE RETURNED METER PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. THE SYSTEM PERFORMED WITHIN EXPECTATIONS. A REVIEW OF THE ENTIRE TESTING HISTORY FOR LOT 382952 WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 382952 MEETS RELEASE CRITERIA. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE IMPEDANCE CURVES FOR THE CUSTOMER'S RESULTS OF 4.8 AND 5.0 WERE STATISTICALLY ANALYZED AND WERE CONCLUDED TO BE NORMAL IN SHAPE, NOT EXHIBITING WEAK SLOPE OR OTHER ABNORMALITIES. 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

    A VARIANCE BETWEEN INRATIO INR RESULT AND LAB INR RESULT WAS REPORTED. THE RESULTS WERE AS FOLLOWS: ON (B)(6) 2016 INRATIO INR=5.0, REPEAT 4.8; LAB INR=3.5. REPORTED THERAPEUTIC RANGE: 3.0-3.5. (NOTE: THE INRATIO2 PRODUCT HS0100139 IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO A SAME OR SIMILAR DEVICE BEING AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279705 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS0100139 382952

    Patients

    Seq Age Sex Outcome Treatment
    1