BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2716244 · Received August 24, 2012

    Report

    Report Number
    2027969-2012-01243
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    July 24, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PATIENT 1 WAS REPORTED TO HAVE BEEN BRIDGING FROM LOVENOX THERAPY AT THE TIME OF TESTING. LOVENOX IS A MEMBER OF A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW­ MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE. LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." DUE TO THIS PATIENT­ SPECIFIC AND OFF-LABEL ISSUES, NO FURTHER CORRELATION ANALYSIS OF THE REPORTED RESULTS IS APPROPRIATE. NO PRODUCT ASSOCIATED WITH THE COMPLAINT IS EXPECTED FOR RETURN. IN-HOUSE THERAPEUTIC DONOR TESTING WITH RETAIN STRIPS WAS PERFORMED WITH REPORTED LOT NUMBER 273314. TEST RESULTS AS FOLLOWS: DONOR 1: INRATIO RESULTS: (2.2, 2.5, 2.2); REF: 2.01; BIAS THRESHOLD (1.01 - 3.01); %CV: 7.53. DONOR 2: 2.3, 2.5, 2.2; 2.03; (1.03 - 3.03); 6.55. ALL REPLICATES FOR EACH DONOR ARE WITHIN ACCEPTABLE BIAS FOR ACCURACY. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRODUCT PERFORMED AS EXPECTED. CONCLUSION: REVIEW OF COMPLAINT FOUND PATIENT'S MEDICATIONS MAY HAVE DELAY ONSET. THEY COULD AFFECT TEST RESULTS. REVIEW OF RECENT IN-HOUSE THERAPEUTIC SAMPLE TESTING FOUND RETAIN STRIPS MET ACCURACY AND PRECISION CRITERIA. AS REVIEWED ON 08/08/2012, ELEVEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT NUMBER 273314 YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QUALITY ASSURANCE FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. 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 FOR PATIENT 1. RESULTS AS FOLLOWS: PATIENT 1: DATE: (B)(6) 2012: INRATIO2 = 4.4, LAB = 2.3. THERAPEUTIC RANGE: 2.0 - 3.0. LAB DRAW TAKEN WITHIN MINUTES OF THE FINGERSTICK ONCE RESULTS WERE SEEN TO BE HIGH ON THE INRATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 273314

    Patients

    Seq Age Sex Outcome Treatment
    1