BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6672793 · Received June 28, 2017

    Report

    Report Number
    1823260-2017-01357
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 8, 2017
    Report Date
    August 3, 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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). NO STRIPS REMAIN TO BE RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. A SPECIFIC ROOT CAUSE FOR THIS EVENT COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. NO INFORMATION WAS PROVIDED IN THE CASE THAT WOULD POINT TO A CAUSE FOR THE DISCREPANT RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER OBTAINED A QUESTIONABLE RESULT ON A CAPILLARY BLOOD SAMPLE USING A COAGUCHEK XS METER, SERIAL NUMBER (B)(4), WHEN COMPARED TO HIS DOCTOR'S COAGUCHEK BRAND PROFESSIONAL METER. THE INITIAL METER RESULT WAS 1.7 INR. THE CUSTOMER SAW A QC CHECK MARK ICON DISPLAYED AFTER THE RESULT. SIX HOURS LATER, THE CUSTOMER TESTED WITH HIS DOCTOR'S METER WITH A RESULT OF 2.5 INR. THIS RESULT WAS BELIEVED TO BE ACCURATE. IT WAS UNKNOWN WHETHER A NEW FINGER WAS USED FOR EACH TEST. NO ADVERSE EVENT OCCURRED. THE CUSTOMER DID NOT RECEIVE TREATMENT FOR THE RESULT OF 1.7 INR.  THE CUSTOMER¿S THERAPEUTIC RANGE IS 2.0-2.5 INR.  THE CUSTOMER IS NOT ANEMIC, HAS NO HEMATOCRIT ISSUES NOR ANTIPHOSPHOLIPID ANTIBODIES. HE IS NOT TAKING HEPARIN OR DIRECT THROMBIN INHIBITORS. THE CUSTOMER HAD TAKEN PLAVIX FROM (B)(6) 2017, AFTER HIS SCHEDULED SURGERY ON (B)(6) 2017. THE METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION; HOWEVER, NO STRIPS REMAINED FOR RETURN. REPLACEMENT WAS SENT.  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. THE RETENTION MATERIAL MET THE SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453317 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 15288123

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR FLOMAX| GABAPENTIN| GLIPIZIDE| LISINOPRIL| PLAVIX| WARFARIN