BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6715683 · Received July 14, 2017

    Report

    Report Number
    2027969-2017-00113
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    November 27, 2016
    Report Date
    September 12, 2017
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Removal / Correction Number
    Z-2354, 2362-2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. THE COMPLAINT LOT 385941 EXPIRED PRIOR TO ALERE OBTAINING THE COMPLAINT; IN-HOUSE TESTING OF THE DEVICE LOT WAS NOT POSSIBLE. HOWEVER, DEVICE LOTS 385940 AND 385942, WHICH ORIGINATE FROM THE SAME BRICK LOT AS THE COMPLAINT LOT, WERE PREVIOUSLY TESTED IN-HOUSE. IN-HOUSE TESTING OF THESE STRIP LOTS MET RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ADDITIONAL INFORMATION WAS PROVIDED IN A LETTER RECEIVED SEPTEMBER 12, 2017. THIS LETTER INCLUDED THE LOT NUMBER OF THE TEST STRIPS USED. THE MDR HAS BEEN UPDATED TO REFLECT THE NEW INFORMATION AND THE UPDATED INVESTIGATION USING THE LOT NUMBER PROVIDED. (REPORT TYPE) HAS BEEN UPDATED TO REFLECT THIS REPORT IS ONLY BEING FILED AS A SERIOUS INJURY. THE ADDITIONAL INFORMATION RECEIVED DOES NOT EVIDENCE A REPORTABLE VARIANCE OR A MALFUNCTION OF THE DEVICE. (DATE OF EVENT) UPDATED TO REFLECT EVENT DATE OF AS (B)(6) 2016. (DATE OF THIS REPORT) UPDATED TO REFLECT DATE OF INFORMATION CONTAINED IN LETTER AS 09/12/2017. (SUSPECT MEDICAL DEVICE) HAVE BEEN UPDATED TO REFLECT NEW INFORMATION PROVIDED. (PREMARKET IDENTIFICATION) UPDATED TO REFLECT APPROPRIATE 510K OF K110212. (LABELED FOR SINGLE USE) UPDATED TO YES TO REFLECT NEW INFORMATION. (EVENT PROBLEM AND EVALUATION CODES) UPDATED TO REFLECT FINDINGS OF CURRENT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: FURTHER INVESTIGATION TO DETERMINE WHETHER THE PRODUCT FAILED TO MEET SPECIFICATIONS CANNOT BE PURSUED BECAUSE THE CUSTOMER DID NOT RETURN THE PRODUCT AND DID NOT PROVIDE A LOT NUMBER. THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED IN A LETTER RECEIVED SEPTEMBER 12, 2017: THE PATIENT BEGAN USING THE INRATIO SYSTEM IN 2009. ON (B)(6) 2016, THE PATIENT SUFFERED A MASSIVE LEFT EYEBALL EFFUSION WITH A DIAGNOSIS OF A SUBCONJUNCTIVAL HEMORRHAGE. THE PATIENT THEN WENT TO THE HOSPITAL WHERE HE WAS PRESCRIBED ANTI-COAGULANTS. ON (B)(6) 2016, THE PATIENT TESTED USING THE INRATIO SYSTEM AND RECEIVED AN INR RESULT OF 5.4. THE PATIENT SUBSEQUENTLY STOPPED TAKING THE PRESCRIBED ANTI-COAGULANTS. WHEN THE PATIENT ATTEMPTED TO OBTAIN ADDITIONAL TEST STRIPS, THE PATIENT WAS INFORMED OF THE INRATIO SYSTEM WITHDRAWAL. THE PATIENT THEN DECIDED TO PURCHASE A ROCHE SYSTEM TO MONITOR HIS INR. ON (B)(6) 2016, THE PATIENT RECEIVED AN INR RESULT OF 3.1 USING THE ROCHE SYSTEM. THE PATIENT'S EYE EVENTUALLY RETURNED TO NORMAL BUT THE HEMORRHAGE LEFT A PERMANENT COSMETIC DEFECT. ORIGINAL EVENT DESCRIPTION: WHILE TESTING USING THE INRATIO SYSTEM, THE PATIENT REPORTEDLY SUFFERED FROM AN EYE STROKE IN (B)(6) 2016. THE PATIENT ALLEGES THAT INACCURATE INRATIO INR RESULTS MAY HAVE CAUSED THE EYE STROKE EVENT.

    Description of Event or Problem · 1

    WHILE TESTING USING THE INRATIO SYSTEM, THE PATIENT REPORTEDLY SUFFERED FROM AN EYE STROKE IN (B)(6) 2016. THE PATIENT ALLEGES THAT INACCURATE INRATIO INR RESULTS MAY HAVE CAUSED THE EYE STROKE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495946 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 99007EU 385941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other