BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5490953 · Received March 9, 2016

    Report

    Report Number
    2027969-2016-00154
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, IN-HOUSE TESTING WAS PERFORMED ON THE REPORTED LOT NUMBER. RETAIN STRIP TESTING RESULTS MET ACCURACY CRITERIA. NO PRODUCT DEFICIENCY WAS FOUND FOR STRIP LOT K382424. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES; THE LOT MET RELEASE SPECIFICATION. THE CUSTOMER REPORTEDLY ENTERED AN INCORRECT STRIP CODE PRIOR TO PERFORMING THE TEST. THE CODE ON THE MONITOR DISPLAY SHOULD MATCH WITH THE STRIP CODE ON THE PACKAGING LABELS OR TEST STRIP POUCH. THIS CANNOT BE RULED OUT AS THE CAUSE OF THE 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

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    A VARIANCE WAS REPORTED BETWEEN INRATIO INR RESULTS AND LAB INR RESULTS. THE RESULTS WERE AS FOLLOWS: INRATIO INR=3.9; LAB INR=1.08. ANOTHER MEASUREMENT WAS TAKEN ON THE SAME DAY AND SAME TIME USING A DIFFERENT INSTRUMENT AS FOLLOWS: INRATIO INR=0.9; LAB INR=1.

    Description of Event or Problem · 1

    A VARIANCE WAS REPORTED BETWEEN INRATIO INR RESULT AND LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: INRATIO INR=3.6; LAB INR=1. THE CUSTOMER CHANGED INSTRUMENT AND MEASURED THE INRATIO INR AGAIN WITH A RESULT OF 0.9. THE CUSTOMER WAS A MALE NURSE WHO IS NOT ON ANY ANTICOAGULANT. IT WAS REPORTED THAT THE FIRST TIME HE USED THE INRATIO WITH LOW BATTERY AND IT WAS ALSO SET ON A WRONG STRIP CODE. (NOTE: THE INRATIO2 PRODUCT 99008G1 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.)

    Description of Event or Problem · 1

    THE INITIAL MEDWATCH REPORT INCLUDED RESULTS THAT WERE NOT CORRECT. THE CORRECT INFORMATION IS AS FOLLOWS: A VARIANCE WAS REPORTED BETWEEN INRATIO INR RESULTS AND LAB INR RESULTS. THE RESULTS WERE AS FOLLOWS: INRATIO INR=3.9; LAB INR=1.08. ANOTHER MEASUREMENT WAS TAKEN ON THE SAME DAY AND SAME TIME USING A DIFFERENT INSTRUMENT AS FOLLOWS: INRATIO INR=0.9; LAB INR=1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146528 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K382424

    Patients

    Seq Age Sex Outcome Treatment
    1