BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1998936 · Received February 16, 2011

    Report

    Report Number
    2027969-2011-00344
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED DUE TO IMPROPER TECHNIQUE. CUSTOMER WAS MILKING THE FINGER. PER PRODUCT USER GUIDE - PRECAUTIONS AND WARNINGS, "DO NOT USE REPETITIVE PRESSURE TO COLLECT THE SAMPLE." SQUEEZING THE FINGER STICK SITE EXCESSIVELY (MILKING) RELEASES INTERSTITIAL FLUID AND MAY CAUSE INACCURATE RESULTS. FINGER STICKING WAS PERFORMED WHILE THE METER WAS WARMING UP AND MULTIPLE DROPS WERE POSSIBLY USED. THIS MAY AFFECT COAGULATION TEST AND CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. PREVIOUS INVESTIGATION OF STRIP LOT # 234130 MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. AS OF 02/15/2011, 73 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 234130 YIELDING A COMPLAINT RATE OF 0.065%. 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 ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 1.7; LAB: 3.4. THERAPEUTIC RANGE: 2.5 TO 3.5. FINGER STICKING PERFORMED WHEN METER IS WARMING UP, NOT AT "APPLY SAMPLE" PROMPT. MILKING INVOLVED. MULTIPLE DROPS POSSIBLY USED. CAPILLARY TUBES USED DUE TO SHAKING HANDS (PT STATED THAT CAP TUBE WAS REUSED, BUT CLEANS THEM THOROUGHLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 NI