BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1610214 · Received February 12, 2010

    Report

    Report Number
    2027969-2010-00166
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 18, 2010
    Report Date
    February 12, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.0, REFERENCE: 1.5, MEAN: 1.75, CONFIDENCE LIMITS: 1.2-2.3. CUSTOMER'S RESULTS WERE ANALYZED AND ACCURACY CONFIDENCE LIMITS WERE MET. IT WAS INDICATED THAT PT MAY HAVE RECENTLY BEEN ON HEPARIN OR LOW MOLECULAR WEIGHT HEPARIN (LMWH). THERE IS INSUFFICIENT INFO TO RULE OUT HEPARIN. PT MAY HAVE ALSO BEEN ON ANTIBIOTICS. PT CONDITIONS AND TREATMENTS MAY HAVE AFFECTED TEST RESULTS. IN-HOUSE ACCURACY TEST INVESTIGATION WAS PERFORMED WITH RETURNED METER AND RETAINED STRIPS. ACCURACY CRITERIA WAS MET. METER FUNCTIONAL TESTING WAS PERFORMED AND MET ALL TESTING CRITERIA. VISUAL INSPECTION REVEALED A SLIGHT CONTAMINATION ON THE HEATER PLATE. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. NO FURTHER INVESTIGATION WILL BE PURSUED. AS OF 02/11/2010, ONE DISCREPANT RESULT COMPLAINT WAS REPORTED FOR LOT# 222167 YIELDING A COMPLAINT RATE OF 0.000%. 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 RESULT: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF LOT #222167 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 2.0, LAB: 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222167

    Patients

    Seq Age Sex Outcome Treatment
    1 NI