BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2221676 · Received August 15, 2011

    Report

    Report Number
    2027969-2011-01822
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 3.7, REFERENCE: 1.9, MEAN: 2.80, CONFIDENCE LIMITS: 1. - 3.8. INRATIO: 3.8, 2.7, 3.25, 1.9 - 4.6. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED . NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PT IS TAKING LISINOPRIL, TOPROL, SIMVASTATIN, MULTIVITAMIN, FISH OIL. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." (B)(4) . ACTION THRESHOLD (B)(4) WAS REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE Z45BU WITH BRICK LOT# 246544, WHICH WAS SPLIT INTO TWO DIFFERENT LOTS (#243104 AND 251117). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL ACTION THRESHOLD OF (B)(4), NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.7, LAB: 1.9. DATE: (B)(6) 2011, 3.8, 2.7. PT'S THERAPEUTIC RANGE: 2.0 - 3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 NI