BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5808766 · Received July 20, 2016

    Report

    Report Number
    2027969-2016-00524
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Report Date
    January 29, 2019
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION G-4: THE DATE RECEIVED BY MANUFACTURER WAS INCORRECTLY REPORTED AS 07/19/2016 IN 2027969-2016-00524 FOLLOW-UP #2. FOLLOW-UP #3 HAS BEEN CREATED TO CORRECT THE DATE RECEIVED BY MANUFACTURER TO 07/11/2016.

    Additional Manufacturer Narrative · 1

    UPDATE: PATIENT'S THERAPEUTIC RANGE 2.5 - 3. PATIENT HAD NO BLEEDING OR HOSPITALIZATION. ADDITIONAL INFORMATION: PATIENT CLAIMS TO HAVE RECEIVED AN INR OF 11 ON INRATIO, NO DATE PROVIDED. THE MAXIMUM RANGE FOR INRATIO IS >7.5.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER DID NOT REPORT A LOT NUMBER IN THE COMPLAINT. RETAIN STRIPS WERE CHOSEN FOR METER INVESTIGATION PURPOSES. DURING THE INVESTIGATION, RESULTS WITH AN IMPEDANCE CURVE EXHIBITING A WEAK-SLOPE CHANGE WERE OBSERVED. DISCREPANT RESULTS CAUSED BY WEAK-SLOPE CHANGES ARE RELATED TO THE SOFTWARE PRESENT IN THE METER; THIS ISSUE WAS ADDRESSED IN CAPA (B)(4). FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED METER WITH PASSING RESULTS. WITH THE EXCEPTION OF THE WEAK-SLOPES OBSERVED DURING IN-HOUSE TESTING, IN-HOUSE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE MANUFACTURING BATCH RECORDS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT PROVIDE A LOT NUMBER AT THE TIME OF THE COMPLAINT. IMPEDANCE CURVE ANALYSIS WAS NOT PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY RESULTS. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. CAPA (B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA (B)(4) FOR THIS ISSUE. CORRECTIONS: BRAND NAME: REMOVED INRATIO PT/INR TEST STRIPS (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO2 PT MONITORING SYSTEM (MONITOR) MODEL #: REMOVED INRATIO PT/INR TEST STRIP AND ADDED THE MONITOR MODEL 200432. LOT#: REMOVED INRATIO PT/INR TEST STRIP LOT NUMBER AND INCLUDED SERIAL NUMBER OF MONITOR AS ABOVE. CONCOMITANT MEDICAL PRODUCTS: REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. THE 510K#: REMOVED THE INRATIO PT/INR TEST STRIP 510K# K092987 AND ADDED K072727 TO REFLECT THE INRATIO2 PT MONITORING SYSTEM. LABELED FOR SINGLE USE?: CHANGED FROM "YES" TO "NO" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. USAGE OF DEVICE: CHANGED FROM "UNKNOWN" TO "REUSE" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. DATE RECEIVED BY MANUFACTURER: CHANGED 02/04/2015 TO 07/19/2016.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER DID NOT REPORT A LOT NUMBER IN THE COMPLAINT. RETAIN STRIPS WERE CHOSEN FOR METER INVESTIGATION PURPOSES. DURING THE INVESTIGATION, RESULTS WITH AN IMPEDANCE CURVE EXHIBITING A WEAK-SLOPE CHANGE WERE OBSERVED. DISCREPANT RESULTS CAUSED BY WEAK-SLOPE CHANGES ARE RELATED TO THE SOFTWARE PRESENT IN THE METER; THIS ISSUE WAS ADDRESSED IN CAPA-(B)(4). FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED METER WITH PASSING RESULTS. WITH THE EXCEPTION OF THE WEAK-SLOPES OBSERVED DURING IN-HOUSE TESTING, IN-HOUSE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE MANUFACTURING BATCH RECORDS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT PROVIDE A LOT NUMBER AT THE TIME OF THE COMPLAINT. IMPEDANCE CURVE ANALYSIS WAS NOT PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY RESULTS. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. CAPA-(B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA-(B)(4) FOR THIS ISSUE.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). REPORT RECEIVED OF DISCREPANT INRATIO VALUES. PATIENT'S THERAPEUTIC RANGE NOT PROVIDED. NO SPECIFIC INR VALUES REPORTED. NO COMPARATIVE TESTING REPORTED. NO DATES FOR INRATIO INR VALUES PROVIDED. CALLER ALLEGED PATIENT HAD BLEEDING AND BRUISES AND HER DOCTOR DID NOT WANT HER TO CONTINUE USING THE METER. NO DATES PROVIDED FOR BLEEDING AND BRUISING. IT IS NOT KNOW IF THERE WAS ANY REQUIRED INTERVENTION. NO TREATMENT INFORMATION, IF ANY, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462144 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SERIAL #(B)(4)