BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1589800 · Received January 19, 2010

    Report

    Report Number
    2027969-2010-00076
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 19, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 4.0, 2ND INR: 2.7, MEAN: 3.35, SD: 0.92, %CV: 27.44. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.6, REFERENCE: 2.6, MEAN: 2.60, CONFIDENCE LIMITS: 1.6-3.4. DATA ANALYSIS ON INITIAL PRECISION COMPARISON TEST DATA PROVIDED BY END-USER REVEALED PRECISION CRITERIA WAS NOT MET. STRIP LOT INVESTIGATION FROM A PREVIOUS CASE REVEALED THAT PRECISION CRITERIA WAS MET. FOLLOW-UP ACCURACY CORRELATION TEST REVEALED INRATIO REFERENCE VALUES ARE IDENTICAL. PATIENT IS ANEMIC. HCT LEVEL IS NOT PROVIDED. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S DISCREPANT RESULT. AS OF 01/18/2010, TEN DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #220375 YIELDING A COMPLAINT RATE OF 0.002%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QC FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. DONOR 1; IN-HOUSE (INR): 3.5, IN-HOUSE (INR): 3.6, IN-HOUSE (INR): 3.4, MEAN: 3.50, SD: 0.10, %CV: 2.86, RESOLUTION: PASS. DONOR 2: IN-HOUSE (INR): 2.8, IN-HOUSE (INR): 2.8, IN-HOUSE (INR): 2.6, MEAN: 2.73, SD: 0.12, %CV: 4.22, RESOLUTION: PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE OF STRIP LOT 220375, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 2.86% AND 4.22%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INR: 4.0, 2.7. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INRATIO: 2.6, LAB: 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 220375

    Patients

    Seq Age Sex Outcome Treatment
    1 NI