BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3851840 · Received April 11, 2014

    Report

    Report Number
    2027969-2014-00331
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED DISCREPANT LOW INRATIO INR RESULT DURING TESTING. THE CUSTOMER DID NOT PROVIDE A REFERENCE VALUE FOR COMPARISON TESTING FOR THE INRATIO INR RESULT OF 1.6 ON (B)(6) 2014. THE ACCURACY OF THE CUSTOMER'S INRATIO INR RESULT COULD NOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION. IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE RETAIN TESTING WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WER OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUES AND IMPROPER USE OF THE METER WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. FURTHER INVESTIGATION WILL NOT BE PURSUED AT THIS TIME. 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

    'CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE REFERENCE METER. RESULTS AS FOLLOWS 2014': DATE; (B)(6) 2014, INRATIO; 2.3, 1.6. DOCTOR'S POC METER; 4.3 (EXACT RESULT NOT SHOWN). TIME BETWEEN TESTING ON 3/13/2014 WAS A FEW MINUTES. THERAPEUTIC RANGE: 2.5-3.5. PATIENT SELF TESTER MILKING FINGER AFTER FINGERSTICK; METER NOT IN CORRECT MODE WHEN FINGERSTICK PERFORMED; ADDED MULTIPLE DROPS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221184 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO 100071 333863

    Patients

    Seq Age Sex Outcome Treatment
    1 CHANGES IN ANY OTHER MEDS, LIST NOT PROVIDED.| COUMADIN 2.5MG 5 DAYS A WK & NONE SUNDAY/WEDNESDAY| ALDACTONE, CHANGED FROM 3X DAILY TO 2X DAILY ON| MARCH 6TH. DOSAGE OF ALDACTONE NOT PROVIDED. NO| METER SERIAL#: (B)(4)