CoaguChek XS Patient Self Testing Care KitRecalls & reported problems across all models

We found 2 models of CoaguChek XS Patient Self Testing Care Kit by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 346 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2018 and Jul 27, 2026 — classified as 15 injuries, 331 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (169 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CoaguChek XS Patient Self Testing Care Kit problems

CoaguChek XS Patient Self Testing Care Kit models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CoaguChek XS Patient Self Testing Care Kit 03666794001

  Test, Time, Prothrombin
  212 reports
• CoaguChek XS Patient Self Testing Care Kit 4837738001

  TEST, TIME, PROTHROMBIN
  134 reports

Recent CoaguChek XS Patient Self Testing Care Kit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026High Test Results

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50001112 ↗
• MalfunctionJul 17, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857881 ↗
• MalfunctionJun 22, 2026Low Test Results

  IT WAS ALLEGED THAT A PATIENT RECEIVED DISCREPANT RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). AT 9:05 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 3.0 INR. AT 9:08 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 2.0 INR. THE PATIENT'S THERAPEUTIC RANGE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25581168 ↗
• MalfunctionJun 9, 2026Circuit Failure; Use of Device Problem

  WE RECEIVED AN ALLEGATION OF A COAGUCHEK XS METER SOFTWARE MALFUNCTION FOR ONE PATIENT. THE CUSTOMER INITIALLY CALLED DUE TO ERROR 3. DURING THE CALL, THE CUSTOMER ALLEGED THAT THE METER GAVE RESULTS USING EXPIRED TEST STRIPS. THE CUSTOMER REPORTED THE FOLLOWING METER RESULTS: ON (B)(6) 2026, THE METER RESULT WAS 2.6 INR. ON (B)(6) 2026, THE METER RESULT WAS 3.3 INR. ON (B)(6) 2026, THE METER RESULT WAS 3.9 INR. THE THERAPEUTIC RANGE IS 2-3 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448812 ↗
• MalfunctionJun 1, 2026Display Difficult to Read

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK XS METER AFFECTING THE INTERPRETATION OF RESULTS. THE CUSTOMER ALLEGED THAT WHILE ATTEMPTING TO TEST, AN ERROR MESSAGE WAS DISPLAYED ON THE SCREEN, WHICH FLUCTUATED BETWEEN SHOWING " ERROR + 5" AND "ERROR + 9". WITH THE ASSISTANCE OF TECHNICAL SUPPORT, THE CUSTOMER PERFORMED A TEST, AND THE RESULT APPEARED TO BE 1.9 INR, BUT THEN THE RESULT CHANGED FROM 1.9 INR TO 1.4 INR. THE THERAPEUTIC RANGE WAS 2.0 INR - 4.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347329 ↗
• MalfunctionMay 11, 2026Image Display Error/Artifact; Lack of Maintenance Documentation or Guidelines

  THERE WAS AN ALLEGATION THAT THE COAGUCHEK XS PST CARE KIT GAVE A RESULT OF 24 INSTEAD OF 2.4 INR. IT IS UNCLEAR IF THERE IS AN ISSUE WITH THE DISPLAY OR IF THE METER IS SET IN THE INCORRECT UNIT OF MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135313 ↗
• MalfunctionApr 16, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED WITH THE COAGUCHEK XS PST CARE KIT METER. THE METER RESULT AT 9:44 AM WAS 7.7 INR. THE METER RESULT AT 9:48 AM WAS 5.7 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 INR - 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895575 ↗
• MalfunctionApr 14, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS METER. AT 3:13 P.M., THE METER RESULT WAS 2.4 INR. AT 3:16 P.M., THE METER RESULT WAS 1.9 INR. AT 4:57 P.M., THE METER RESULT WAS 3.4 INR. AT 5:42 P.M., THE METER RESULT WAS 1.1 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. THE PATIENT STOPPED TAKING THEIR WARFARIN MEDICATION FOR 2 DAYS BASED ON THE RESULT OF 1.1 INR AND CONFIRMED NO HARM OR SERIOUS INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877030 ↗
• MalfunctionApr 2, 2026Device Difficult to Setup or Prepare; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COAGUCHEK XS METER. IT WAS REPORTED THAT THE METER DISPLAYED A RECURRING "SET + DATE FLASH" ERROR, AND THE PATIENT WAS UNABLE TO INITIATE A MEASUREMENT. THE ISSUE WAS NOT RESOLVED BY REBOOTING THE METER. IT WAS ALSO NOTED THAT THE METER'S TIME AND DATE WERE INCORRECTLY SET. THE METER RESULT WAS 1.5 INR AT 09:44 AM. THE METER RESULT WAS 2.4 INR AT 11:01 AM. THE METER RESULT WAS 1.4 INR AT 02:12 PM. IT COULD NOT BE CONFIRMED IF THE RESULT TIMES WERE ACCURATE OR IF THEY WERE PERFORMED WITHIN 4 HOURS. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 INR - 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765458 ↗
• MalfunctionJan 12, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE HIGH INR RESULT FOR ONE PATIENT TESTED WITH THE COAGUCHEK XS PST METER, WHEN COMPARED WITH ANOTHER COAGUCHEK METER. THE METER RESULT AT THE DOCTOR'S OFFICE WAS 2.5 INR, WHILE THE PATIENT'S METER RESULT WAS 5.0 INR. THE TIME DIFFERENCE BETWEEN THE MEASUREMENTS WAS WITHIN MINUTES. THE PATIENT¿S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036054 ↗
• MalfunctionJan 8, 2026Adverse Event Without Identified Device or Use Problem

  THERE WAS AN ALLEGATION OF A QUESTIONABLE INR RESULT USING THE COAGUCHEK XS PT TEST 6 STRIP WITH THE COAGUCHEK XS PST CARE KIT FOR ONE PATIENT. THE INITIAL RESULT AT 6:41 PM WAS 4.3 INR, AND ANOTHER RESULT AT 6:55 PM WAS 5.6 INR. THE PATIENT WAS NOT SURE IF HER HANDS WERE COMPLETELY DRY WHEN DOING THE FIRST TEST.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24009889 ↗
• MalfunctionSep 22, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). THE CUSTOMER STATED TWO SEGMENTS ON THE LEFT SIDE OF THE FIRST NUMBER APPEARED FADED. THEY WERE UNABLE TO DETERMINE IF IT WAS A 3 OR 8. THE TOP SEGMENT AND BOTTOM SEGMENT WAS MISSING FROM THE SECOND NUMBER. UNABLE TO DETERMINE IF IT'S A 1 OR 7. THEIR LAST RESULT WAS A 3.1 INR OR 8.7 INR DUE TO THE MISSING/FADED SEGMENTS. CUSTOMER REPORTED THE RESULT AS A 3.1 INR AND THEIR WARFARIN DOSE WAS ADJUSTED ACCORDINGLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111288 ↗
• InjurySep 5, 2025Circuit Failure; Circuit Failure

  THERE WAS AN ALLEGATION OF AN ADVERSE EVENT FOR ONE PATIENT WHILE USING THE COAGUCHEK XS METER. THE PATIENT ALLEGED THE METER WAS NOT AVAILABLE FOR USE DUE TO A POWER ISSUE ONE WEEK PRIOR TO HOSPITALIZATION. THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL ON (B)(6) 2025 DUE TO HEART FAILURE, A COLLAPSED LUNG, HIGH INR LEVELS, AND RENAL FAILURE. THE PATIENT ALLEGED THE RESULT FROM THE HOSPITAL LAB UPON ADMISSION WAS 5.5 INR. THE PATIENT ALLEGED THAT WARFARIN WAS STOPPED WHEN ADMITTED. THE PATIENT REPORTED SHE DID NOT RECEIVE VITAMIN K BUT WAS UNSURE OF WHICH MEDICATIONS WERE GIVEN. IT WAS REPORTED THAT 2.5 LITERS OF FLUID WERE REMOVED FROM HER RIGHT LUNG, WHICH HAD COLLAPSED. THE PATIENT ALLEGED THERE WAS BLOOD IN THE FLUID THAT WAS REMOVED. THE PATIENT WAS REPORTEDLY IN THE HOSPITAL FOR FIVE DAYS. THE PATIENT¿S CURRENT CONDITION WAS REPORTED TO BE STABLE. THE PATIENT¿S THERAPEUTIC RANGE WAS PROVIDED AS 2.0-3.0 INR, AND THE PATIENT TESTED ONCE A MONTH. THE PATIENT FOLLOWS A DIABETIC DIET, A WARFARIN DIET, A LOW-SODIUM DIET, AND A HEART-HEALTHY DIET.

  Patient problems: Coagulation Disorder

  MAUDE report 22979857 ↗
• MalfunctionAug 14, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE ON A COAGUCHEK XS METER. THE CUSTOMER STATED THAT THE METER DISPLAY IS FADED AND MISSING SEGMENTS. THEY ALSO ALLEGED THAT THEY RECEIVED A RESULT OF 1.2 INR, BUT THEY WERE NOT SURE AS THE RESULTS WERE FADED. THE CUSTOMER PERFORMED A DISPLAY CHECK AND CONFIRMED THAT THERE WERE MISSING SEGMENTS IN THE NUMBER 8 ON THE DISPLAY SCREEN. THE CUSTOMER ALSO CHANGED THE BATTERIES ON THE METER AND THE SCREEN WAS STILL FADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805872 ↗
• MalfunctionJul 16, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS A METER DISPLAY ISSUE WITH COAGUCHEK XS METER, SERIAL NUMBER (B)(6). CUSTOMER ALLEGED THE METER HAD A DISPLAY MALFUNCTION THAT RESULTED IN A MISINTERPRETATION OF RESULTS. THE RESULTS FIELD OF THE METER IS FADED. THE RESULTS FIELD DISPLAYED A RESULT OF 5.4 INR ON THE DAY OF THE EVENT. CUSTOMER DID NOT BELIEVE THIS WAS THE CORRECT RESULT DUE TO THE DISPLAY ISSUE. THE CUSTOMER DID NOT REPORT THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521917 ↗

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