BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1646989 · Received March 25, 2010

    Report

    Report Number
    2027969-2010-00353
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 25, 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: 6.4, 2ND INR: 4.6, MEAN: 5.50, SD: 1.27, %CV: 23.14. A 4.7 INR WAS EXCLUDED FROM COMPARISON TEST DUE TO PENDING LAB RESULTS: DATA ANALYSIS OF CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED PRECISION CRITERIA WAS NOT MET. NO PRODUCT IS EXPECTED TO BE RETURNED. PRECISION TEST RECORDS WERE REVIEWED. TESTING DONE ON A PREVIOUS CASE WITH RETAINED STRIPS FROM STRIP LOT #220375 INDICATED THAT PRECISION CRITERIA WAS MET. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCIES. AS OF 03/25/2010, SEVENTEEN DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #220375 YIELDING A COMPLAINT RATE OF 0.004%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS: TEST DATE: (B) (6) 2010. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. TWO REPLICATES FOR DONOR 1 DID NOT MEET THE CRITERIA. TWO MORE DONORS WILL BE TESTED TO ELIMINATE THE POSSIBILITY THAT THE FAILURE IS DUE TO DONOR SPECIFIC EFFECT. ADDITIONAL TESTING: SEE SCANNED TABLE. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE OF STRIP LOT 220375, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 5.44% AND 2.48%, 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 INVESTIGATION WILL BE PURSUED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INR: 6.4, 4.6. CALLER ALSO ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 4.7, LAB: NG.

    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