BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2311044 · Received September 26, 2011

    Report

    Report Number
    2027969-2011-02014
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 26, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED BECAUSE CUSTOMER WAS TAKING LOVENOX. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." RECENT TEST CONDUCTED ON LOT 253023 ON 09/16/2011 MET BOTH ACCURACY AND PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 104 = 3.3, 3.3, 3.1 INR; DONOR 105 = 2.9, 2.9, 2.9 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 104 (3.20 INR) AND DONOR 105 (2.38 INR), RESPECTIVELY. IN-HOUSE TEST RESULTS HAVE 3.57% AND 0.00%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME.(B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION, 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

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: UNK; INRATIO: 5.9; LAB: UNK. DATE: (B)(6) 2011; INRATIO: 5.8; LAB: UNK. UNK DATE WAS STATED TO BE "ABOUT A WEEK AGO" ON (B)(6) 2011. THE LAB INR RESULT ON THIS DATE WAS STATED TO BE >10. THE LAB INR VALUE ON (B)(6) 2011 WAS STATED TO BE >8. CUSTOMER DID NOT HAVE EXACT INR LAB RESULTS, BUT THOUGHT THAT THESE WERE AROUND THE RIGHT VALUE. LAB DRAWS WERE PERFORMED WITHIN MINUTES OF METER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253023

    Patients

    Seq Age Sex Outcome Treatment
    1