BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5976327 · Received September 26, 2016

    Report

    Report Number
    1823260-2016-01460
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 17, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    TWO VIALS OF THE CUSTOMER'S TEST STRIP LOT 121353-11 WERE RECEIVED. BOTH VIALS CONTAINED MORE THAN 10 TEST STRIPS. THE TEST STRIPS AND VIALS SHOWED NO DEFECTS. THE RETURNED TEST STRIPS WERE TESTED WITH A RETENTION METER WITH TWO CONTROL SAMPLES. CONTROL SAMPLE FROM LOT 10005250 (SPECIFIED TARGET RANGE 2.1-3.2 INR); CONTROL SAMPLE FROM LOT 10006065 (SPECIFIED TARGET RANGE 1.5-2.3 INR). CUSTOMER STRIPS WITH RETENTION METER: CONTROL LOT 10005250 2.7 INR AND 2.6 INR; CONTROL LOT 10006065 1.9 INR AND 1.9 INR. ALL CONTROL VALUES WERE WITHIN THE SPECIFIED TARGET RANGES AND NO ERROR MESSAGES OCCURRED. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION. DEVICE EVALUATION BY MANUFACTURER AND DEVICE RETURNED TO MANUFACTURER WERE UPDATED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE DOCTOR STATED THERE HAVE BEEN VARIED RESULTS ON THE METER. THE RESULTS FROM THE METER WERE 7.0 INR, 4.6 INR, AND 2.9 INR. THE RESULTS FROM A LABORATORY USING THROMBOREL S (HUMAN TISSUE THROMBOPLASTIN) WAS 3.4 INR. THERE WERE "0 HOURS" BETWEEN THE COLLECTIONS. THE RESULTS WERE REPORTED TO THE PATIENT AND/OR MEDICAL PERSONNEL TREATING THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE THERAPEUTIC RANGE WAS 2.0 - 3.0 INR. IT WAS NOTED THE PATIENT "HAD VERY THIN BLOOD" AND WAS A LONG TERM WARFARIN PATIENT WITH A CONSISTENT DOSE. THE PATIENT HAD NO AUTOIMMUNE DISEASE, RENAL OR LIVER INSUFFICIENCY, OR MALIGNANT DISEASE. THE SUSPECT STRIPS AND METER WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 121353-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124 158 80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION STRIPS/REFERENCE METER: MARCUMAR 1: 2.2 INR; MARCUMAR 2: 2.3 INR. MASTER LOT /REFERENCE METER: MARCUMAR 1: 2.1 INR; MARCUMAR 2: 2.2 INR. THE OBTAINED RESULTS SHOWED A MAXIMUM DIFFERENCE OF 0.1 INR BETWEEN RETENTION SAMPLES AND MASTERLOT. NO ERROR MESSAGES OCCURRED AND RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628723 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 121353-11

    Patients

    Seq Age Sex Outcome Treatment
    1