BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7306760 · Received March 1, 2018

    Report

    Report Number
    1823260-2018-00619
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    August 1, 2017
    Report Date
    April 17, 2018
    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 · 0

    THE SUSPECTED PRODUCT WAS NOT RETURNED FOR FURTHER INVESTIGATION. WITHOUT THE RETURNED SUSPECTED PRODUCT THE INVESTIGATION IS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. THE SUSPECTED PRODUCT WAS NOT RETURNED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A PATIENT STATED THAT HER INR RESULTS WERE HIGH AND SHE DID NOT TRUST THE ACCURACY OF HER COAGUCHEK XS WITH A SERIAL NUMBER OF (B)(4). IN (B)(6) 2017 ON THE DAY PRIOR TO EYE SURGERY, THE PATIENT HAD A RESULT OF 4.4 INR ON HER METER. AN HOUR LATER USING THE HOSPITAL'S COAGUCHEK XS METER SHE GOT A RESULT OF 2.4 INR. THE PATIENT STATED SHE DID NOT FEEL HER METER WAS ACCURATE AND SHE FELT THE HOSPITAL'S METER WAS ACCURATE. THE PATIENT COULD NOT REMEMBER THE SPECIFIC DATE. ON (B)(6) 2018, THE PATIENT TOOK HER COAGUCHEK XS METER WITH HER TO A DIALYSIS APPOINTMENT AND GOT A RESULT OF 5.0 INR ON HER METER. THE NURSE TESTED THE PATIENT WITH THE HOSPITAL'S COAGUCHEK XS METER AT THE SAME TIME USING A DIFFERENT FINGER AND THE RESULT WAS 3.5 INR. THE PATIENT STATED SHE DID NOT FEEL HER METER WAS ACCURATE AND SHE FELT THE HOSPITAL'S METER WAS ACCURATE. THE PATIENT STATED SHE USED HER METER AND STRIPS FOR HER RESULT WHILE THE NURSE USED THEIR METER AND STRIPS. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON THESE INR RESULTS. THE PATIENTS THERAPEUTIC RANGE WAS 2.5 - 3.5 INR. THE PATIENT IS LEGALLY BLIND AND HER HUSBAND PERFORMS HER INR TESTING EACH TIME. THE PATIENT AND HER HUSBAND DO NOT WASH THEIR HANDS PRIOR TO TESTING. THE PATIENT IS ANEMIC BUT THE HEMATOCRIT VALUE WAS REQUESTED BUT NOT PROVIDED. THE PATIENT DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES, IS NOT ON HEPARIN, AND IS NOT ON DIRECT THROMBIN INHIBITORS. THE PATIENT IS NOT ON ANY NEW MEDICATIONS, DID NOT HAVE THEIR COUMADIN DOSAGE CHANGED, HAS HAD NO CHANGES TO THEIR DIET, HAS NOT HAD ANY NEW ILLNESSES, OR ANY BLEEDING OR BRUISING. THE SUSPECTED PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150327 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR COUMADIN