BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2251697 · Received August 31, 2011

    Report

    Report Number
    2027969-2011-01907
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER MILKED THE FINGER PRIOR TO TESTING. 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. IN THE FIRST TEST, CUSTOMER TOOK A LONG TIME GETTING THE BLOOD TO THE STRIP AFTER FINGER STICK WAS PERFORMED. BLOOD WAS APPLIED TO THE STRIP FASTER IN THE SECOND TEST. THIS MAY AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR OR ERRORS IN TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, FIRST INR: 4.6, SECOND INR: 1.4, MEAN: 3.0, SD: 2.26, PERCENT CV: 75.42. SINCE PERCENT CV IS MORE THAN 20 PERCENT, THE TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT NUMBER 257060 ON 08/09/2011 MET PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 84= 2.8, 2.6, 2.7 INR; DONOR 85= 3.7, 3.5, 4.0 INR. IN-HOUSE TEST RESULTS HAVE 3.70 PERCENT AND 6.74 PERCENT , RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16 PERCENT CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TESTING RESULTS FOR THIS LOT MET ACCURACY CRITERIA. IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT AND COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.6, RE-TEST: 1.4. TESTS WERE DONE FIVE MINUTES APART. PATIENT'S LAST DOSE OF COUMADIN WAS THREE DAYS AGO. THE CUSTOMER IS PREPPING FOR SURGERY AND HAS BEEN TAKEN OFF ALL MEDICATIONS. THE NURSE STATED SHE MILKED THE FINGER PRIOR TO TESTING. SHE ALSO SAID IT TOOK HER LONGER TO GET THE BLOOD TO THE STRIP AFTER THE FINGER WAS PRICKED FOLLOWING ACTIVATION OF THE GREEN LIGHT. THE CUSTOMER SAID SHE HAD A HARD TIME WITH THE PATIENT. THE SECOND TIME AROUND SHE GOT THE BLOOD TO THE STRIP FASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 257060

    Patients

    Seq Age Sex Outcome Treatment
    1