BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2710953 · Received August 20, 2012

    Report

    Report Number
    2027969-2012-01221
    Event Type
    Malfunction
    Date Received
    August 20, 2012
    Date of Event
    March 1, 2011
    Report Date
    August 20, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO2 TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT TWO OUT OF THREE PATIENTS' INRATIO2 AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. PATIENT 1 AND 3'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PATIENT 2'S INRATIO2 AND REFERENCE TEST RESULT COMPARISON DID MEET ACCURACY CRITERIA. RETURNED METERS AND RETAINED STRIPS WERE TESTED AND REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. AS REVIEWED ON 05/24/2011, (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD MONITORED BY QA FOR CORRECTIVE ACTION ((B)(4)), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FOR RETURNED METERS (1), (2), AND (3) SN: (B)(4) AND RETAINED STRIP LOT #240450: THE RETURNED UNIT'S MEMORY WAS DOWNLOADED AND REVIEWED. INR RESULTS REPORTED ARE REGISTERED ON UNIT'S MEMORY, BUT INR RESULTS REPORTED WERE NOT FOUND ON UNIT S/N: (B)(4). THE ALLOWABLE DIFFERENCES BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WERE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES TESTED ON STRIP LOT #240450 ARE WITHIN THE ALLOWABLE BIAS (+/-1.0). NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED. METER INSPECTION INVESTIGATION ON SN (B)(4) (1): UNIT WAS TESTED WITH THERMOMETER SENSING TEST DURING WARM UP TO DETERMINE IF UNIT'S HEATER PLATE IS WITHIN THE ACCEPTABLE TEMPERATURE RANGE (36.00 - 38.00 DEGREES C). PERFORMED THERMOMETER SENSING TEST ON UNIT AND BOTH THERMISTOR WERE MEASURED AS FOLLOWS: THERMISTOR #1 = 36.12 DEGREES C THERMISTOR #2 = 36.20 DEGREES C. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER DECK, WHICH HAS NOT AFFECTED THE PERFORMANCE OF TEMPERATURE CONTROL CIRCUITRY. METER INSPECTION INVESTIGATION ON SN (B)(4) (2): UNIT WAS TESTED WITH THERMOMETER SENSING TEST DURING WARM UP TO DETERMINE IF UNIT'S HEATER PLATE IS WITHIN THE ACCEPTABLE TEMPERATURE RANGE (36.00-38.00 DEGREES C). PERFORMED THERMOMETER SENSING TEST ON UNIT AND BOTH THERMISTOR WERE MEASURED AS FOLLOWS: THERMISTOR #1 = 36.10 DEGREES C THERMISTOR #2 = 36.20 DEGREES C. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER DECK, WHICH HAS NOT AFFECTED THE PERFORMANCE OF TEMPERATURE CONTROL CIRCUITRY. METER INSPECTION INVESTIGATION ON SN (B)(4) (3): UNIT WAS THEN TESTED WITH THERMOMETER SENSING TEST DURING WARM UP TO DETERMINE IF UNIT'S HEATER PLATE IS WITHIN THE ACCEPTABLE TEMPERATURE RANGE (36.00-38.00 DEGREES C). PERFORMED THERMOMETER SENSING TEST ON UNIT AND BOTH THERMISTOR WERE MEASURED AS FOLLOWS: THERMISTOR #1 = 36.10 DEGREES C THERMISTOR #2 = 36.20 DEGREES C. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER DECK, WHICH HAS NOT AFFECTED THE PERFORMANCE OF TEMPERATURE CONTROL CIRCUITRY.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: PATIENT 1: DATE: (B)(6) 2011, INRATIO2: 1.5, LAB: 4.2; PATIENT 2: DATE: (B)(6) 2011, INRATIO2: 1.8, LAB: 2.7; PATIENT 3: DATE: (B)(6) 2011, INRATIO2: 1.5, LAB: 3.7. CUSTOMER USED 3 DIFFERENT INRATIO2 METERS FOR COMPARISONS. PLEASE SEE MFR. REPORT #2027969-2011-00634 AND #2027969-2012-01220 FOR OTHER METERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 240450

    Patients

    Seq Age Sex Outcome Treatment
    1 NI