BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7252553 · Received February 8, 2018

    Report

    Report Number
    1823260-2018-00375
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 17, 2018
    Report Date
    February 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 10:51 AM, THE RESULT FROM THE METER WAS 6.9 INR. THE CUSTOMER DID NOT BELIEVE THE RESULT AND STATED THEY SQUEEZED THE FINGER EXCESSIVELY. AT 11:41 AM, THE RESULT FROM A NEW FINGER WAS 3.9 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT AND THE CUSTOMER DID NOT RECEIVE MEDICAL TREATMENT. THE CUSTOMER WAS NOT ANEMIC, NO HEPARIN, NO ANTIPHOSPHOLIPID ANTIBODIES, AND NO DIRECT THROMBIN INHIBITOR. THE CUSTOMER STATED THAT HE WOULD NOT TAKE HIS WARFARIN DOSE THAT EVENING. THE CUSTOMER HAD STARTED TAKING METOPROLOL. THE CUSTOMER HAS NOT HAD A NEW ILLNESS. HE DID HAVE BRONCHITIS AND WAS TAKING AN ANTIBIOTIC AND NYQUIL PRIOR TO THE EVENT. THE CUSTOMER HAS NOT HAD ANY DIET CHANGES. THE CUSTOMER HAS HAD NO SYMPTOMS OF BLEEDING AND ONLY GETS NORMAL BRUISING FOR BEING ON A BLOOD THINNER. NO MEDICAL TREATMENT WAS NEEDED FOR THE BRUISING. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE TESTING FREQUENCY WAS WEEKLY. THE PHYSICIAN PREFERS THE PATIENT TO BE 3.0 INR. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL PERFORMED AS SPECIFIED. THE CUSTOMER'S RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR #1 INR: 2.1 INR, DONOR #2 INR: 2.1 INR . DONOR #1 HCT: 44%, DONOR #2 HCT: 48%. TESTING RESULTS: DONOR #1: MASTER LOT: 2.1 INR, DONOR #1: CUSTOMER METER AND STRIP: 2.0 INR. DONOR #2: MASTER LOT: 2.1 INR, DONOR #2: CUSTOMER METER AND STRIP: 2.0 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET THE SPECIFICATION. THE INVESTIGATION DETERMINED THAT EXCESSIVELY SQUEEZING THE FINGER COULD AFFECT THE INTEGRITY OF THE RESULTS DISPLAYED BY THE METER. PRODUCT LABELING STATES MASSAGE YOUR FINGER FROM ITS BASE. IF NEEDED, IMMEDIATELY AFTER LANCING, GENTLY SQUEEZED YOUR FINGER FROM ITS BASE TO ENCOURAGE BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98023 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR