BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6440233 · Received March 28, 2017

    Report

    Report Number
    1823260-2017-00656
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 7, 2017
    Report Date
    March 28, 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

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED ERROR MESSAGES AND QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). AROUND 9:16 A.M., THE CUSTOMER STATED HE RECEIVED AN UNKNOWN ERROR ON THE METER. A DISPLAY CHECK WAS PERFORMED AND VERIFIED ALL SEGMENTS OF THE DISPLAY WERE PRESENT. DURING A PHONE CONVERSATION WITH TECHNICAL SUPPORT, THE CUSTOMER TESTED AND THE RESULT WAS 4.9 INR WHICH HE STATED HE WAS GOING TO REPORT TO THE DISTRIBUTOR AND THEN FOLLOW UP WITH HIS PHYSICIAN. AROUND 11:21 A.M. THE CUSTOMER CALLED BACK STATING THAT HE ATTEMPTED TO RETEST, BUT DID NOT GET A RESULT. DURING THE PHONE CONVERSATION WITH TECHNICAL SUPPORT, THE CUSTOMER TESTED WITH A NEW FINGER AND THE RESULT WAS 6.4 INR. THE CUSTOMER WAS ADVISED TO FOLLOW UP WITH THE PHYSICIAN. A SECOND VIAL OF THE SAME LOT NUMBER OF STRIPS WAS USED FOR THE SECOND TEST. THE CUSTOMER'S THERAPEUTIC RANGE IS 2-3 INR. THE CUSTOMER HAD NO HEMATOCRIT ISSUE, NO HEPARIN, NO DIRECT THROMBIN INHIBITOR, AND NO ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER'S COUMADIN DOSE HAD NOT CHANGED. THERE WERE NO NEW MEDICATIONS, NO CHANGES IN DIET, NO ADDITIONAL ILLNESSES, NO BLEEDING OR BRUISING. THE CUSTOMER REFUSED TO PROVIDE FURTHER INFORMATION REGARDING HIS CONDITION. RELEVANT RETENTION TEST STRIPS (LOT 152881-23) 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 SUSPECT METER AND TWO TEST STRIPS WERE RETURNED FOR INVESTIGATION AND 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 INR: 3.2 INR AND 2.2 INR, DONOR HCT: 33% AND 40%. TESTING RESULTS: DONOR 1: MASTER LOT / CUSTOMER STRIP AND METER, 3.2 INR/ 3.0 INR. DONOR 2: MASTER LOT / CUSTOMER STRIP AND METER, 2.2 INR/ 2.2 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATION. UPON RECEIPT OF THE METER, REVIEW OF THE ERROR REPORT SHOWED MULTIPLE ERROR MESSAGES INDICATING "STRIP EXPIRY DATE AFTER MEASUREMENT START LOWER THAN INSTRUMENT DATE" AROUND THE TIME OF THE INITIAL TESTING. THE DATE OF THE METER AT THE TIME OF THESE ERRORS WAS SET TO (B)(6) 2018. PER THE ERROR REPORT, THE DATE ON THE METER WAS SUBSEQUENTLY CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222573 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 15288123

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR COUMADIN