BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2100150 · Received May 12, 2011

    Report

    Report Number
    2027969-2011-01076
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 12, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 2.4, 2ND INR: 1.2, MEAN: 1.80, SD: 0.85, %CV: 47.14. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON (B)(4) 2011 REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. (SEE BELOW). INVESTIGATION RESULTS FOR RETAINED STRIP LOT #247451: DONOR 1: 1ST INR: 2.2, 2ND INR: 2.1, 3RD INR: 2.3, MEAN: 2.20, SD: 0.10, %CV: 4.55. DONOR 2: 4.2, 3.7, 4.2, 4.03, 0.29, 7.16. PERCENT CV FOR BOTH DONORS ARE BELOW 20%. PRECISION CRITERIA WAS MET. NO FURTHER TESTING IS NEEDED. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935 ASSOCIATED TO BRICK LOT #237418, WHICH WAS ASSIGNED AND PACKAGED INTO STRIP LOTS (247450 AND 247451). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.4, 1.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI