BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1692614 · Received May 13, 2010

    Report

    Report Number
    2027969-2010-00576
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    March 16, 2010
    Report Date
    May 13, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY). COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: THREE HRS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. TEST 7 HAS A VALUE ABOVE 5.0 AND IS NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED TO HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. INVESTIGATION: 2.9, 4.1 AND 3.9 INR ARE REGISTERED ON UNIT'S MEMORY (B) (4). THE PRODUCT IN COMPLAINT FAILED ON EXTERNAL POWER. DEFECTIVE POWER PORT HAS BEEN CONFIRMED. AA BATTERIES ARE UTILIZED FOR INRATIO 1 (B) (4). METER INVESTIGATION (FUNCTIONAL TEST PLAN/INSPECTION): SINCE UNIT IS UNABLE TO POWER UP WITH AC POWER SUPPLY, AA BATTERIES ARE UTILIZED DURING TESTING. UNIT WAS THEN TESTED WITH THERMOMETER SENSING TEST DURING WARMING UP TO DETERMINE IF UNIT'S HEATER PLATE IS WITHIN THE STANDARD SPECIFICATION (36.00-38.00 DEGREES CELSIUS). PERFORMED THERMOMETER SENSING TEST ON UNIT AND BOTH THERMISTOR ARE MEASURED AS FOLLOWS: THERMISTOR #1 = 36.22 DEGREES CELSIUS THERMISTOR #2 = 36.18 DEGREES CELSIUS. VISUAL INSPECTION REVEALED ADHESIVE RESIDUES ON STRIP GUIDE AND SIGNIFICANT CONTAMINATION ON HEATER DECK, AND IT MAY HAVE AFFECTED THE PERFORMANCE OF TEMP CONTROL UNIT. METER FUNCTIONAL TEST PLAN WAS PERFORMED AND EXTERNAL POWER FAIL IS OBTAINED. A TOTAL OF 3 COMPLAINTS HAVE BEEN REPORTED FOR LOT# 222166 YIELDING A COMPLAINT RATE OF 0.015%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ALERT LEVEL OF 0.05% AND THE ACTION THRESHOLD OF 0.1%; CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: INRATIO: 1.2. TEST WAS FROM A NURSING ADMINISTRATION TEST STUDY. STUDY PERFORMED WITH (3) PT'S OVER (7) DAYS. PT INFO WAS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222166

    Patients

    Seq Age Sex Outcome Treatment
    1