BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5331320 · Received December 28, 2015

    Report

    Report Number
    2027969-2015-01029
    Event Type
    Injury
    Date Received
    December 28, 2015
    Date of Event
    October 23, 2015
    Report Date
    December 2, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880,0881,0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: BRAND NAME: REMOVED INRATIO PT/INR TEST STRIPS (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO2 PT MONITORING SYSTEM (MONITOR) D4 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 THE MONITOR AS ABOVE CONCOMITANT MEDICAL PRODUCTS: REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. FOR 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. INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. DONOR TESTING WAS PERFORMED WITH THE RETURNED MONITOR AND RETAINED STRIPS OF LOT 366218. LOT 366218 WAS MANUFACTURED CLOSE TO THE CUSTOMER'S REPORTED STRIP LOT AND WAS USED BECAUSE THE CUSTOMER'S EXACT LOT WAS DEPLETED PRIOR TO INVESTIGATION. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVE ASSOCIATED WITH AN IN-HOUSE DISCREPANT RESULT DETERMINED THAT THE CURVE EXHIBITED A WEAK-SLOPE CHANGE. IMPEDANCE CURVES WITH WEAK SLOPE CHANGES CAN RESULT IN DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE SOFTWARE ON THE MONITOR AND WAS ADDRESSED IN CAPA-(B)(4). FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. WITH THE EXCEPTION OF THE WEAK-SLOPE OBSERVED DURING IN-HOUSE TESTING, IN-HOUSE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY FOR STRIP LOT 360632 WAS CONDUCTED. IN-HOUSE TESTING ON STRIP LOT 360632 MEETS EXPECTATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. THERE WAS NO INFORMATION IDENTIFIED IN THE COMPLAINT THAT INDICATED TECHNIQUE ISSUES, IMPROPER STORAGE CONDITIONS, OR PATIENT SAMPLE INTERFERENCE. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN INRATIO INR RESULT AND THE LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: (B)(6) INRATIO INR=2.6, (B)(6) LAB INR=1.2. PATIENT SELF TESTER'S THERAPEUTIC RANGE IS: 2.5-3.5. ON (B)(6) 2015 PATIENT SELF TESTER SUFFERED A STROKE AND WAS TAKEN TO THE HOSPITAL; THE LAB INR=1.2. THE PATIENT SELF TESTER REMAINED IN THE HOSPITAL FOR 22 DAYS. DURING THIS TIME HE SUFFERED A SECOND STROKE. THE CALLER, WIFE OF PATIENT, COULD NOT PROVIDE THE DATE OF THE SECOND STROKE. DURING HIS TIME IN THE HOSPITAL, THE PATIENT SELF TESTER DID NOT TEST AT ALL USING HIS INRATIO MONITOR. CALLER WAS UNABLE TO PROVIDE FURTHER INFORMATION REGARDING ADDITIONAL LAB TESTS DURING THIS PERIOD OF TIME NOR COULD SHE PROVIDE ANY INFORMATION REGARDING TREATMENTS ADMINISTERED. ON (B)(6) 2015, THE PATIENT SELF TESTER WAS CONSIDERED STABLE AND WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853164 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 360632

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L