BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3442196 · Received September 6, 2013

    Report

    Report Number
    2027969-2013-00786
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 16, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTION: DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY CUSTOMER. REVIEWED RETAIN TESTING ON REPORTED LOT NUMBER 304243. INVESTIGATION: THE CUSTOMER WAS ON LOVENOX WHEN THE TESTING WAS PERFORMED. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY. THIS MAY CONTRIBUTE TO UNEXPECTED INR RESULTS OR TESTING ERRORS. BECAUSE OF THE CUSTOMER'S OFF-LABEL USE, ANALYSIS OF THE CUSTOMER'S RESULTS WAS NOT PERFORMED. IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON REPORTED LOT # 304243 ON 08/21/2013. RESULTS ARE FOLLOWS: DONOR: (B)(4), INRATIO: 1.9, 2.1, 1.9, REFERENCE: 1.65, BIAS THRESHOLD: 1.15 - 2;15, %CV: 5.87; 203, 2.5, 2.4, 2.6, 2.50, 150 - 3.50, 4.00. RETENTION PRODUCTS PERFORMED AS EXPECTED. ALL REPLICATES WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY AND YIELDED A %CV OF LESS THAN 16%, PASSING THE PRECISION CRITERIA. NO FURTHER INVESTIGATION WAS REQUIRED. CONCLUSION: THE PT WAS UNDERGOING TREATMENT WITH LOVENOX, A LOW MOLECULAR WEIGHT HEPARIN. LIMITATIONS IN PI, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." THIS CONSTITUTES OFF-LABEL USE. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. AS REVIEWED ON 09/05/2013, (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #304243, YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION: NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECTED TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 7.4, LABORATORY INR: 1.72. THE TIME BETWEEN TESTING WAS THIRTY (30) MINUTES. REPORTEDLY, THE PT WAS ON LOVENOX AT THE TIME OF TESTING. THERAPEUTIC RANGE 2.0 - 3.0 FOR PATIENT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444256 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 304234

    Patients

    Seq Age Sex Outcome Treatment
    1 LOVENOX| WARFARIN