BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6385036 · Received March 7, 2017

    Report

    Report Number
    1823260-2017-00496
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    February 13, 2017
    Report Date
    March 7, 2017
    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

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THEY RECEIVED ERRONEOUS RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE PATIENT HAD A METER RESULT OF 6.6 INR ON (B)(6) 2017. TWO HOURS LATER, THEY USED A NEW SAMPLE FROM THE SAME FINGER AND TESTED IT ON THE METER, RESULTING AS 4.8 INR. ON (B)(6) 2017, THE PATIENT TESTED A SAMPLE ON THE METER AT 9 A.M. AND THE RESULT WAS 4.4 INR. AT 11 A.M., THE CUSTOMER TESTED A NEW SAMPLE FROM A DIFFERENT FINGER ON THE METER AND THE RESULT WAS 2.2 INR. THE PATIENT CONTACTED THEIR DOCTOR IMMEDIATELY AFTER TESTING. THE PATIENT'S THERAPEUTIC RANGE IS 2 - 3 INR. THE PATIENT'S TESTING FREQUENCY IS EVERY TWO WEEKS. THE PATIENT STARTED TAKING COUMADIN 15 YEARS AGO DUE TO A LEAKY HEART VALVE. PRIOR TO TESTING ON (B)(6) 2017, THE PATIENT LAST TOOK HIS COUMADIN DOSE OF 5 MG AT 10 P.M. ON (B)(6) 2017. THE PATIENT IS NOT ANEMIC AND DOES NOT SUFFER FROM ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT IS NOT TAKING HEPARIN OR DIRECT THROMBIN INHIBITORS. THE PATIENT HAS HAD NO CHANGES IN DIET, SUPPLEMENTS, OR VITAMINS. THE PATIENT JUST GOT OVER A COLD AND WAS TAKING CODEINE AND PREDNISONE. THE PATIENT HAS HAD NO SIGNS OF BLEEDING OR BRUISING. NO TREATMENT WAS RECEIVED DUE TO THE EVENT AND MEDICATION DOSAGE WAS NOT CHANGED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. RELEVANT RETENTION TEST STRIPS (LOT 152885-21) 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 MATERIAL PERFORMED AS SPECIFIED. THE RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT TEST STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR 1 INR: 2.6 INR, DONOR 2 INR: 4.7 INR. DONOR 1 HCT: 47%, DONOR 2 HCT: 50%. TESTING RESULTS: DONOR #1: MASTER LOT: 2.7 INR, CUSTOMER STRIP AND METER: 2.6 INR. DONOR #2: MASTER LOT: 4.6 INR, CUSTOMER STRIP AND METER: 4.7 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. UPON REVIEW OF THE METER'S DATA LOGS, THE FOLLOWING RESULT DISCREPANCIES WERE ALSO OBSERVED: 6.2 INR AT 13:53 ON (B)(6) 2002, 4.8 INR AT 14:22 ON (B)(6) 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165547 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 15288521

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR CODEINE| COUMADIN| PACEMAKER| PREDNISONE