BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1347324 · Received March 18, 2009

    Report

    Report Number
    2027969-2009-00135
    Event Type
    Injury
    Date Received
    March 18, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 18, 2009
    Manufacturer
    BIOSITE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED TABLE. END-USER REPORTED ACCURACY DISCREPANT TEST RESULTS. THERE IS INSUFFICIENT DATA TO DETERMINE DISCREPANCY. THE RETURNED METER TESTED IN COMPARISON TO THE SYSMEX PASSED ACCURACY CRITERIA. NO PRODUCT DEFICIENCY ESTABLISHED. IN-HOUSE DISCREPANCY TEST RECORD FOUND STRIP WITHIN ACCURACY CRITERIA. NO FURTHER ACTION REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. AS OF DATE, 15 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #080693 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. THERE HAS BEEN 3 DISCREPANT RESULTS COMPLAINTS REPORTED FOR LOT #080818 YIELDING A COMPLAINT RATE OF 0.001%. DUE TO THIS LOW OCCURENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION IS REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED ISSUES WITH ACCURACY OF THEIR METER. IN 2009: PATIENT OBTAINED A 2.0 INRATIO INR. PATIENT HAD BLOOD IN HIS STOOL BUT DID NOT GO FOR LAB DRAW. FOUR DAYS LATER: PATIENT WAS RUSHED TO THE HOSPITAL DUE TO BLEEDING AND PNEUMONIA. PATIENT WAS IN ICU. NO TEST WAS DONE ON INRATIO METER BUT PATIENT REPORTED HIGH INR AT THE HOSPITAL ER BUT COULD NOT PROVIDE EXACT INR READING. ABOUT THREE DAYS LATER: PATIENT WAS RELEASED FROM THE HOSPITAL. PATIENT TRIED TO TEST WITH HIS INRATIO METER FOR THE FIRST TIME SINCE HE CAME HOME FROM THE HOSPITAL AND OBTAINED ERRORS THREE TIMES. PATIENT IS NOT ON LMWH OR HEPARIN. HCT LEVEL IS UNKNOWN. PATIENT TESTED HIS WIFE=1.0 INRATIO MANUFACTURER DISCUSSED POSSIBLE INTERFERENCE ISSUE AND RECOM TO DO LAB DRAW AND ISSUED REPLACEMENT METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE, INC. 0100007

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization