BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5856511 · Received August 9, 2016

    Report

    Report Number
    2027969-2016-00558
    Event Type
    Injury
    Date Received
    August 9, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K331425 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED METER WITH PASSING RESULTS, HOWEVER DURING THERMISTOR TESTING OF THE HEATER PLATE, BOTH THERMISTORS FAILED TO MEET SPECIFICATION. HOWEVER, IT WAS DETERMINED THAT THE LOWER TEMPERATURE RANGES INVESTIGATED WERE NOT FOUND TO IMPACT PERFORMANCE OF THE METER. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY INRATIO INR RESULT. THE PATIENT DID NOT PROVIDE INRATIO INR RESULTS, COMPARATIVE VALUES, OR REPORTED DATES OF OCCURRENCE. IT IS NOT POSSIBLE TO DETERMINE IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: INCORRECTLY MENTION THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT 387622A WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED METER WITH PASSING RESULTS, HOWEVER DURING THERMISTOR TESTING OF THE HEATER PLATE, BOTH THERMISTORS FAILED TO MEET SPECIFICATION. HOWEVER, IT WAS DETERMINED THAT THE LOWER TEMPERATURE RANGES INVESTIGATED WERE NOT FOUND TO IMPACT PERFORMANCE OF THE METER. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY INRATIO INR RESULT. THE PATIENT DID NOT PROVIDE INRATIO INR RESULTS, COMPARATIVE VALUES, OR REPORTED DATES OF OCCURRENCE. IT IS NOT POSSIBLE TO DETERMINE IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THE PRODUCT WAS RETURNED AND EVALUATED: A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT 387622A WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED METER WITH PASSING RESULTS, HOWEVER DURING THERMISTOR TESTING OF THE HEATER PLATE, BOTH THERMISTORS FAILED TO MEET SPECIFICATION. HOWEVER, IT WAS DETERMINED THAT THE LOWER TEMPERATURE RANGES INVESTIGATED WERE NOT FOUND TO IMPACT PERFORMANCE OF THE METER. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY INRATIO INR RESULT. THE PATIENT DID NOT PROVIDE INRATIO INR RESULTS, COMPARATIVE VALUES, OR REPORTED DATES OF OCCURRENCE. IT IS NOT POSSIBLE TO DETERMINE IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PREVIOUS CORRECTION INCORRECTLY REFERENCED. ADDITIONALLY, IT ALSO INCORRECTLY INCLUDED THE WRONG LOT NUMBER: A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT 387622A WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED METER WITH PASSING RESULTS, HOWEVER DURING THERMISTOR TESTING OF THE HEATER PLATE, BOTH THERMISTORS FAILED TO MEET SPECIFICATION. HOWEVER, IT WAS DETERMINED THAT THE LOWER TEMPERATURE RANGES INVESTIGATED WERE NOT FOUND TO IMPACT PERFORMANCE OF THE METER. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY INRATIO INR RESULT. THE PATIENT DID NOT PROVIDE INRATIO INR RESULTS, COMPARATIVE VALUES, OR REPORTED DATES OF OCCURRENCE. IT IS NOT POSSIBLE TO DETERMINE IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THE CORRECT LOT NUMBER IS K331425: A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K331425 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED METER WITH PASSING RESULTS, HOWEVER DURING THERMISTOR TESTING OF THE HEATER PLATE, BOTH THERMISTORS FAILED TO MEET SPECIFICATION. HOWEVER, IT WAS DETERMINED THAT THE LOWER TEMPERATURE RANGES INVESTIGATED WERE NOT FOUND TO IMPACT PERFORMANCE OF THE METER. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT REPORT ANY INRATIO INR RESULT. THE PATIENT DID NOT PROVIDE INRATIO INR RESULTS, COMPARATIVE VALUES, OR REPORTED DATES OF OCCURRENCE. IT IS NOT POSSIBLE TO DETERMINE IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE ALLEGES THAT THE PATIENT'S INR WAS HIGHER THAN THE INR RESULTS RECEIVED USING THE INRATIO SYSTEM. NO TEST RESULTS OR DATES OF TESTING AVAILABLE. NO CONFIRMATORY TESTING WAS PERFORMED. THERAPEUTIC RANGE IS UNAVAILABLE. BELOW IS A CHRONOLOGY OF EVENTS AS REPORTED BY THE PATIENT'S WIFE: ON (B)(6) 2014: THE PATIENT BEGAN TESTING USING THE INRATIO SYSTEM. ON (B)(6) 2014: THE PATIENT EXPERIENCED TWO EPISODES OF BLEEDING WITH BRUISING AND SWELLING ON HIS RIGHT LEG. THE PATIENT DID NOT RECEIVE ANY MEDICAL CARE AND BLEEDING SYMPTOMS CLEARED WITHIN 3-4 DAYS. THE PATIENT'S WIFE REPORTED THAT SHE BELIEVES THE BLEEDING EPISODES WERE THE RESULT OF A MUSCLE TEAR DURING PHYSICAL THERAPY. DURING THIS TIME PERIOD, THE PATIENT'S WIFE ALLEGES THAT THE PATIENT'S INR WAS HIGHER THAN THE INR RESULTS RECEIVED USING THE INRATIO SYSTEM. ON (B)(6) 2014: THE PATIENT DISCONTINUED USE OF THE INRATIO SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513804 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 K331425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention