BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 10460618 · Received August 27, 2020

    Report

    Report Number
    1823260-2020-02117
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 2, 2020
    Report Date
    December 10, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    1823260-11/16/20-006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H9 WAS UPDATED. DURING THE INVESTIGATION OF THE RETURNED METER, THE ALLEGED RESULT OF 8.4 %Q FROM (B)(6)2020 IS 84 %Q NOT 8.4 %Q. (84 %Q = 1.1 INR). THE UNITS OF THE METER WAS SET TO %Q BY MISTAKE AND THE CUSTOMER DIDN'T REALIZE THE CHANGE IN THE UNIT SETTING. THE CUSTOMER INTERPRETED THE RESULTS FROM THE METER AS %Q BUT WITH AN IMAGINED DECIMAL POINT IN AN ATTEMPT TO INTERPRET THE NUMBER AS AN INR RESULT. THE COAGUCHEK XS METER IS DESIGNED TO READ IN INR, SECONDS AND %QUICK. THE MOST ACCEPTED UNIT OF MEASURE IN THE US IS INR. THE COAGUCHEK IS PROVIDED TO US CUSTOMERS PRE-SET TO THE MEASURING UNIT INR. A CUSTOMER COMMUNICATION WAS PROVIDED TO CUSTOMERS TO ADVISE HOW TO ENSURE THE UNITS ARE IN INR AND HOW TO CHANGE THE UNIT BACK TO INR IF THE UNITS GET CHANGED. LABELING UPDATES WILL BE MADE TO ALL IMPACTED LABELING.

    Additional Manufacturer Narrative · 1

    OCCUPATION IS LAY USER/PATIENT. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE METER WAS RETURNED; THE TEST STRIPS WERE NOT RETURNED. THE METER WAS TESTED USING RETENTION STRIPS AND RETENTION LIN 3 CONTROLS: TESTING RESULTS (QC RANGE = 4.1 - 6.8 INR): QC 1: 5.3 INR QC 2: 5.3 INR QC 3: 5.3 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    THE INITIAL REPORTER ALLEGED THE PATIENT HAD A STROKE DUE TO INR RESULTS DISPLAYING IN %Q FROM A COAGUCHEK XS METER. THE PATIENT USED TEST STRIP LOT 44502621 WITH AN EXPIRATION DATE OF 30-JUN-2021. THE REPORTER HAD INITIALLY NOTICED HIGH RESULTS ON (B)(6) 2020. THE RESULTS WERE DISPLAYING IN %Q, BUT THE REPORTER THOUGHT THE RESULTS WERE BEING DISPLAYED IN INR. THE REPORTER WROTE DOWN THE FOLLOWING %Q RESULTS: (B)(6) 2020: 5.4 %Q SINCE THIS RESULT WAS INTERPRETED TO BE HIGH, THE TEST WAS REPEATED WITH A RESULT OF 5.3%. DUE TO WHAT WERE BELIEVED TO BE HIGH INR RESULTS, THE PATIENT STOPPED TAKING COUMADIN ON (B)(6) 2020 AND DID NOT RESUME. A HIGH INR WILL DISPLAY AS A LOW %Q AND A LOW INR WILL DISPLAY AS A HIGH %Q. (B)(6). THE REPORTER RECEIVED ASSISTANCE CHANGING THE UNITS IN THE SETTINGS TO DISPLAY RESULTS IN INR. THE FOLLOWING RESULTS WERE OBSERVED IN THE MEMORY OF THE METER (ALL DATES DO NOT ALIGN WITH WHAT THE REPORTER HAD WRITTEN DOWN AND THE DATE WAS NOT SET CORRECTLY): (B)(6). THE PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. ON (B)(6) 2020 THE PATIENT WENT TO THE HOSPITAL AT 10:30 A.M. BECAUSE "HE LOOKED STRANGE AND WAS NOT RIGHT." THE PATIENT WAS DIAGNOSED WITH A STROKE (CLOT IN BRAIN); HIS INR WAS 1.1 UPON ADMISSION. THE METER DID NOT MALFUNCTION. THE METER CAN DISPLAY RESULTS IN EITHER %Q OR INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925202 COAGUCHEK XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization ALENDRONATE| AMLODIPINE| ATORVASTATIN| CALCIUM| COUMADIN| FINASTERIDE| FLONASE - AS NEEDED| FOLIC ACID| FUROSEMIDE| K TAB| LISINOPRIL| MAGNESIUM| METOPROLOL| VITAMIN B12