BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1911487 · Received November 18, 2010

    Report

    Report Number
    2027969-2010-02001
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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: 3.2, REFERENCE: 2.4, MEAN: 2.80, CONFIDENCE LIMITS: 1.7-3.8. INRATIO: 1.2, REFERENCE: 2.4, MEAN: 1.80, CONFIDENCE LIMITS: 1.2-2.5. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 3.2, 2ND INR: 1.2, MEAN: 2.20, SD: 1.41, %CV: 64.28. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISONS MEET ACCURACY CRITERIA. HOWEVER, REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT PRECISION CRITERIA WAS MET. PRECISION WAS CALCULATED FROM ACCURACY TEST. %CV OF DONOR 1 = 2.79, WHICH IS LESS THAN 16%. NO FURTHER INVESTIGATION IS REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PATIENT IS TAKING CIPROFLOXACIN, WHICH IS AN ANTIBIOTIC THAT MAY AFFECT COAGULATION TESTING. AS OF 11/18/2010, THIRTY DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #234527 YIELDING A COMPLAINT RATE OF 0.050%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (PATIENT'S WIFE) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.2, LAB: NG. DATE: (B)(6) 2010, INRATIO: 3.2, LAB: 2.4. INRATIO: 1.2, LAB: 2.4. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 3.2, INR: 1.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 234527

    Patients

    Seq Age Sex Outcome Treatment
    1 NI