BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5746536 · Received June 23, 2016

    Report

    Report Number
    2027969-2016-00469
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 4, 2016
    Report Date
    June 6, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    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, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE STRIP TESTING ON STRIP LOT K380861 MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT WAS PERFORMED; THE LOT MET RELEASE SPECIFICATION. UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT. 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

    THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER K380861 WAS NOT INCLUDED IN FOLLOW UP #1 ALTHOUGH THIS INFORMATION WAS PROVIDED PRIOR TO THE FOLLOW UP BEING SUBMITTED. HOWEVER, THE INFORMATION DOES INCLUDE THE INVESTIGATION PERFORMED FOR THIS LOT.

    Description of Event or Problem · 1

    A CALLER REPORTED A VARIANCE BETWEEN THE INRATIO INR RESULT AND ALTERNATE POC INR RESULT. THE RESULTS WERE AS FOLLOWS: (B)(6) 2016: INRATIO INR=2.7, (B)(6) 2016: ALTERNATE POC INR=1.8. THE REPORTED THERAPEUTIC RANGE IS: 2.0-2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400862 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS99007G1 K380861

    Patients

    Seq Age Sex Outcome Treatment
    1