BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5102534 · Received September 24, 2015

    Report

    Report Number
    2027969-2015-00702
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 4, 2013
    Report Date
    September 29, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE DONOR TESTING HAD NOT BEEN PERFORMED FOR THE CUSTOMER'S REPORTED STRIP LOT PRIOR TO EXPIRATION. HOWEVER, IN-HOUSE DONOR TESTING WAS PERFORMED FOR STRIP LOT K301619. STRIP LOTS K301620 AND K301619 ORIGINATE FROM THE SAME MASTER LOT AND ARE IDENTICAL EXCEPT FOR OUTER PACKAGING AND LABELING. RETAIN TESTING RESULTS FOR LOT K301619 MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS FOR STRIP LOTS K301619 & K301620 DID NOT UNCOVER ANY NON-CONFORMANCES. BOTH LOTS MEET RELEASE SPECIFICATION. ROOT CAUSE IS UNABLE TO BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE INR RESULTS WITH THE INRATIO METER ARE ALWAYS LOWER THAN THE LAB INR. RESULTS AS FOLLOWS: (B)(6) 2013; COMARISON MEASURMENTS: (B)(6) 2013: COAGUCHEK, 3.2, INRATIO 2.4 (B)(6) 2013: LAB 2.4, COAGUCHEK 2.5, INRATIO 2.2 (B)(6) 2013: COAGUCHEK 2.8, INRATIO 2.0 (B)(6) 2013: COAGUCHEK 2.2, INRATIO 2.1 (B)(6) 2013: LAB 2.5, COAGUCHEK 2.5, INRATIO 1.2 (B)(6) 2013: COAGUCHEK 2.2, INRATIO 1.6PATIENT'S THERAPEUTIC RANGE IS: 2-3.THE PATIENT REPORTED HIGH CRP RESULTS WHICH COULD BE THE REASON FOR THE DISCREPANT RESULTS. CASE WAS ESCALATED TO ALERE SAN DIEGO ON (B)(6) 2015. THIS CASE WAS IDENTIFIED DURING AN ASSESSMENT/REMEDIATION AS PART OF AN INTERNAL ASD (B)(4) RELATED TO INRATIO COMPLAINTS RECEIVED AT THE ALERE GERMANY INTAKE SITE THAT WERE NOT APPROPRIATELY DOCUMENTED IN THE ELECTRONIC CASE RECORD FOR PROCESSING AND ESCALATION FOR REGULATORY DETERMINATION. THE AVAILABLE INFORMATION IS LIMITED AND NO ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633276 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 K301620

    Patients

    Seq Age Sex Outcome Treatment
    1