BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4359841 · Received December 16, 2014

    Report

    Report Number
    2027969-2014-01091
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 9, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z0080, 0081, 0082-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: SEE NEW INFORMATION PROVIDED BY PATIENT SELF TESTER'S HUSBAND (B)(6). 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. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. REMOVED THE INRATIO PT/INR TEST STRIP 510K# 092987 AND ADDED K072727 TO REFLECT THE INRATIO2 PT MONITORING SYSTEM. LABELED FOR SINGLE USE: CHANGED FROM YES TO NO AS THE MONITOR CAN BE USED MULTIPLE TIMES. INVESTIGATION/CONCLUSION: INRATIO MONITOR SN: (B)(4) WAS RETURNED FOR INVESTIGATION. (THE SECOND MONITOR, SN (B)(4)WAS NOT RETURNED FOR INVESTIGATION). THE COMPLAINT WAS NOT CONFIRMED. RETAIN STRIP TESTING ON THE RETURNED MONITOR MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. INVESTIGATION OF THE RETURNED MONITOR DID NOT UNCOVER ANY DEFICIENCIES. THE MONITOR CONTINUES TO MEET SPECIFICATION. IMPEDANCE CURVE ANALYSIS WAS PERFORMED ON THE CUSTOMER'S INRATIO INR RESULTS. A WEAK SLOPE CHANGE WAS FOUND ON THE 3.8 (STRIP LOT 357499) AND 3.7 (STRIP LOT 355401) CURVES. THIS MADE IT DIFFICULT FOR THE MONITOR TO DETERMINE AN INFLECTION POINT, AND MAY HAVE CAUSED THE MONITOR TO DETERMINE THE PT POINT EARLIER THAN IT SHOULD. THE IMPEDANCE CURVE FOR THE CUSTOMER'S RESULT OF 1.9 (STRIP LOT 355401) WAS ANALYZED AND WAS FOUND TO BE NORMAL IN SHAPE, NOT EXHIBITING CHARACTERISTICS OF A WEAK-SLOPE CHANGE. FURTHER INVESTIGATION INTO THE ISSUES WILL BE PURSUED UNDER CAPA (B)(4). ALSO REFERENCE MEDWATCH REPORT 2027969-2014-01092. A REVIEW OF THE MANUFACTURING RECORDS FOR STRIP LOTS 357499 AND 355401 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOTS MET RELEASE SPECIFICATIONS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS": 12/1 INRATIO(A)=3.8 (LOT 357499), 12/4 INRATIO(A)=3.7, 1.9 (30 MIN APART), (LOT 355401), 12/4 INRATIO (B)=6.5 (1 HR APART), (LOT 355401), 12/4 LAB TEST=>10, (1 HR APART), INRATIO A #105226619, INRATIO B #102503792. THERAPEUTIC RANGE: 2.0-3.0. PATIENT SELF TESTER WAS ADMITTED TO THE HOSPITAL ON (B)(6)2014 FOR ELEVATED CREATININE LEVELS DUE TO KIDNEY DYSFUNCTION AND ELEVATED LAB INR = >10; WAS ADMINISTERED VIT. K. ON (B)(6)2014: PATIENT SELF TESTER WAS SCHEDULED FOR A BIOPSY OF KIDNEY. NO RELEASE DATE STATED. THE INRATIO PT/INR TEST STRIPS LOT #355401 REFERENCED B5 AND D11 IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER 2027969-2014-01092.

    Description of Event or Problem · 1

    HUSBAND OF PATIENT SELF TESTER, (B)(6), PROVIDED MORE INFORMATION. PATIENT SELF TESTER HAD A LAB INR=12 ON (B)(6) 2014; NO INRATIO PERFORMED. SHE WAS ADMINISTERED UNSPECIFIED HEPARIN THERAPY WHILE IN THE HOSPITAL IN ADDITION TO THE VITAMIN K MENTIONED IN THE INITIAL MEDWATCH REPORT. ACCORDING TO THE HUSBAND, HIS WIFE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2014 UNDER NURSES CARE. VENOUS BLOOD TESTS ARE CONTINUING TO BE PERFORMED UNTIL DIAGNOSIS OF KIDNEY BIOPSY IS CONFIRMED. BOTH PATIENT SELF TESTER AND HUSBAND REQUIRE LIVING ASSISTANCE DUE TO PREVIOUS MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825282 INRATIO2 PT MONITORING SYSTEM GJS ALERE SAN DIEGO, INC. 200432 357499

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SECOND MONITOR LOT#355401| WARFARIN| HEPARIN| VIT.K IN HOSPITAL| MONITOR SN: (B)(4)