BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6072412 · Received November 2, 2016

    Report

    Report Number
    1823260-2016-01702
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 14, 2016
    Report Date
    December 12, 2016
    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
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S TEST STRIPS WERE PROVIDED FOR INVESTIGATION AND MEASURED WITH A RETENTION METER IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. TESTING RESULTS: DONOR #1: MASTERLOT AND RETENTION METER - 2.4 INR FROM VIAL 1. 2.4 INR FROM VIAL 2. CUSTOMER STRIPS AND RETENTION METER - 2.4 INR FROM VIAL 1. 2.3 INR FROM VIAL 2. DONOR #2: MASTERLOT AND RETENTION METER - 3.5 INR FROM VIAL 1. 3.5 INR FROM VIAL 2. CUSTOMER STRIPS AND RETENTION METER - 3.5 INR FROM VIAL 1. 3.5 INR FROM VIAL 2. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS. RELEVANT RETENTION TEST STRIPS (LOT 128043) 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 DETERMINED TO BE ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS RETURNED FOR INVESTIGATION. THE METER SERIAL NUMBER IS (B)(4). THE RETURNED METER & MASTERLOT 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. TESTING RESULTS: DONOR #1: MASTER LOT AND RETENTION METER: 2.4 INR, CUSTOMER METER AND MASTER LOT STRIP: 2.4 INR. DONOR #2: MASTER LOT AND RETENTION METER: 3.0 INR, CUSTOMER METER AND MASTER LOT STRIP: 2.9 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET SPECIFICATIONS. IT WAS DETERMINED THAT TESTING ON 10/14/2016 DID NOT OCCUR ON THIS METER AS THERE IS NOT A 4.0 INR RESULT IN THE METER MEMORY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT TESTED ON A COAGUCHEK XS METER. THE SERIAL NUMBER OF THE METER WAS ASKED FOR, BUT NOT PROVIDED. THE RESULT FROM THE CUSTOMER'S METER WAS 4.0 INR AT 12:30 P.M. AND THIS RESULT WAS TOO HIGH. AT THE PHYSICIAN'S OFFICE, THE CUSTOMER WAS TESTED ON THE SAME TYPE OF ROCHE METER FROM THE OFFICE, RESULTING AS 1.4 INR AT 2:30 P.M. A DIFFERENT FINGER STICK WAS USED FOR EACH TEST. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE CUSTOMER'S TEST STRIPS WERE USED FOR BOTH TESTS OR IF THE PHYSICIAN'S OFFICE USED THEIR OWN STRIPS FOR THE COMPARISON TEST. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE PATIENT'S THERAPEUTIC RANGE IS 2 - 3 INR. THE PATIENT IS NOT ANEMIC AND THE PATIENT'S FINGERS WERE DRY. THE PATIENT HAD NO BRUISING THAT REQUIRED TREATMENT AND DOES NOT SUFFER FROM ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT RECEIVES NO HEPARIN OR DIRECT THROMBIN INHIBITORS. THE PATIENT'S WARFARIN DOSE WAS INCREASED BASED UPON THE OFFICE METER RESULT OF 1.4 INR. THE PATIENT WAS INFORMED TO HAVE INR RE-TESTED IN ONE WEEK USING THE PHYSICIAN'S METER. PRODUCT FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724267 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 12804321

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR ASPIRIN| COREG| WARFARIN