BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2572609 · Received May 8, 2012

    Report

    Report Number
    2027969-2012-00665
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 6, 2012
    Report Date
    May 8, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO DATA ANALYSIS WAS PERFORMED BECAUSE CUSTOMER WAS BRIDGING FROM LOVENOX. LOVENOX IS A CLASS OF ANTI-THROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARIN (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." NO PRODUCT ASSOCIATED WITH THE COMPLAINT IS EXPECTED FOR RETURN. IN-HOUSE THERAPEUTIC DONOR TESTING WITH RETAIN STRIPS WAS PERFORMED WITH REPORTED LOT NUMBER 272566. TEST RESULTS ARE AS FOLLOWS: (B)(6). ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAS BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. CONCLUSION: REVIEW OF COMPLAINT DESCRIPTION REVEALED THAT PT WAS ON HEPARIN/COUMADIN BRIDGING. PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." THIS MAY HAVE CONTRIBUTED TO UNEXPECTED LOW RESULT. NO PRODUCT WAS EXPECTED TO BE RETURNED. IN-HOUSE THERAPEUTIC SAMPLE TESTING WITH RETAIN STRIPS MET ACCURACY AND PRECISION CRITERIA. AS REVIEWED ON (B)(6) 2012, NINE (9) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT 272566 YIELDING A COMPLAINT RATE OF 0.007%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF 0.07%, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB ON ONE PT. RESULTS AS FOLLOWS: DATE: (B)(6) 2012; INRATIO: 1.0; LAB: 1.9. PT HAD A LOW INR ON THE INRATIO METER SO THE NURSE SENT THE PT TO THE LAB. THE LAB TESTING WAS DONE HALF AN HOUR LATER WITH VENIPUNCTURE. PT AS BRIDGING LOVENOX/COUMADIN. PT'S THERAPEUTIC RANGE IS (2-3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 272566

    Patients

    Seq Age Sex Outcome Treatment
    1