BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1692616 · Received May 13, 2010

    Report

    Report Number
    2027969-2010-00577
    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. METER INVESTIGATION: UNIT IS UNABLE TO POWER UP WITH AC POWER SUPPLY, AA BATTERIES ARE UTILIZED DURING TESTING. UNIT WAS 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 = 36.33 DEGREES CELSIUS THERMISTOR #2 = 36.29 DEGREES CELSIUS. VISUAL INSPECTION REVEALED SLIGHT CONTAMINATION ON HEATER PLATE, BUT IT HAS NOT AFFECTED THE PERFORMANCE OF TEMP CONTROL UNIT. METER FUNCTIONAL TEST PLAN WAS PERFORMED; TESTS WERE COMPLETED WITH "PASS". A TOTAL OF 3 COMPLAINTS HAVE BEEN REPORTED FOR LOT# 226219 YIELDING A COMPLAINT RATE OF 0.001%. 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: 1.0, INRATIO: 1.0, INRATIO: 1.0. TESTS WERE FROM A NURSING ADMINISTRATION TEST STUDY: ONE PT, PERFORMED AT DIFFERENT TIMES. TEST 2 USED STRIP LOT# 222166. TEST 1 AND 3 USED STRIP CODE 066KH. 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 226219

    Patients

    Seq Age Sex Outcome Treatment
    1