BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000203 · Received February 18, 2011

    Report

    Report Number
    2027969-2011-00368
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.0, 2ND INR: 1.9, MEAN: 1.45, SD: 0.64, %CV: 43.89. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT TEST RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 1: RETURN: 2.4, IN-HOUSE1: 2.4, IN-HOUSE2: 2.8, %CV: 9.11. DONOR 2: 2.1, 1.9, 2.0, 5.0. SINCE %CV FOR BOTH DONORS FALL BELOW PRECISION THRESHOLD OF 20%, PRECISION CRITERIA WAS MET. NO FURTHER INVESTIGATION REQUIRED. PER ISSUE, PT IS TAKING ANTIBIOTICS. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (EG., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." AS OF 2/18/2011, TWENTY-TWO DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 237433, YIELDING A COMPLAINT RATE OF 0.007%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.0, 1.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 237433

    Patients

    Seq Age Sex Outcome Treatment
    1 NI