BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2060627 · Received April 8, 2011

    Report

    Report Number
    2027969-2011-00759
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    January 24, 2011
    Report Date
    April 8, 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
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON RESULTS BECAUSE CUSTOMER USED EXPIRED STRIPS AS WELL AS 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 FINGERSTICK SITE EXCESSIVELY (MILKING) RELEASES INTERSTITIAL FLUID AND MAY CAUSE INACCURATE RESULTS. IN ADDITION, THE TIME BETWEEN REPEATED INRATIO TEST RESULTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. STRIP LOT #227285 IN COMPLAINT EXPIRED ON 02/28/2011. SINCE THE RELEASE OF THIS STRIP LOT, THREE IN-HOUSE THERAPEUTIC SAMPLE TESTS (18 STRIPS) WERE PERFORMED ON RETAINED AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER (PATIENT'S HUSBAND) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.9, LAB: 2.2. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 6.7. DATE: (B)(6) 2011, INRATIO: 2.1. PATIENT REDUCED COUMADIN BY HALF THE DOSE ON (B)(6) 2011. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 227285

    Patients

    Seq Age Sex Outcome Treatment
    1 NI