CoaguChek XS Patient Self Testing Care Kit 03666794001Recalls & reported problems

Summary

The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 04015630945689), received between Jul 17, 2018 and Sep 22, 2025 — classified as 8 injuries, 204 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (107 reports).

4 other recalls cover devices cleared under the same FDA submission (K062925); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 212 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 19, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER'S COAGUCHEK XS METER SERIAL NUMBER (B)(6) HAD A DISPLAY ISSUE IMPACTING THE RESULTS FIELD. THE CUSTOMER REPORTS THE METER DISPLAY IS FADED AND LED TO THEM MISINTERPRETING A RESULT. ON (B)(6) 2025, THE CUSTOMER TESTED AND REPORTED A RESULT OF 2.6 INR. THE DISPLAY WAS FADED AT THE TIME OF THE TEST. THE CUSTOMER HAD NO THERAPY CHANGES BASED ON THE RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE DISPLAY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045777 ↗
• MalfunctionMar 24, 2025Circuit Failure; Circuit Failure

  THERE WAS AN ALLEGATION OR AN ELECTRICAL ISSUE WITH COAGUCHEK XS METER, SERIAL NUMBER (B)(6). CUSTOMER ALLEGED AN ELECTRICAL SHORT ISSUE. THERE IS A BURNT SPOT INSIDE OF THE BATTERY COMPARTMENT. THE CUSTOMER BELIEVES THE BURNT SPOT WAS CAUSED BY AN ELECTRICAL SHORT. THERE WAS NO HARM TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677178 ↗
• MalfunctionMar 6, 2025Device Difficult to Setup or Prepare; Inadequate User Interface; Non Reproducible Results; Device Difficult to Setup or Prepare; Inadequate User Interface; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE THAT AFFECTED THE DISPLAY OF THE COAGUCHEK XS METER. PER THE METER MEMORY, THE RESULT AT 7:51 AM WAS >8.7 INR. THIS RESULT WAS OUTSIDE OF THE METER¿S MEASURING RANGE. PER PRODUCT LABELING FOR THE DEVICE: THE COAGUCHEK XS PT TEST STRIPS PROVIDE TEST RESULTS IN THE MEASURING RANGE OF 0.8 TO 8.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535707 ↗
• MalfunctionJan 3, 2024Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK METER. THE REPORTER STATED THAT THE METER HAD BEEN IN STORAGE FOR A COUPLE OF MONTHS. THE REPORTER INSTALLED NEW BATTERIES AND THE METER WOULD POWER ON BUT WITH ONLY A PARTIAL DISPLAY. A DISPLAY CHECK AND METER MEMORY CHECK WERE PERFORMED AND THE RESULTS FIELD WAS ONLY PARTIALLY VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436641 ↗
• MalfunctionDec 21, 2023Off-Label Use; Off-Label Use

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK XS METER. THE REPORTER STATED WHEN THE METER IS POWERED ON, SHE ONLY SEES SEGMENTS AT THE TOP LEFT AND TOP RIGHT OF THE SCREEN. WHEN TEST STRIPS ARE INSERTED, SHE CAN SEE SEGMENTS IN THE MIDDLE OF THE SCREEN AND AT THE TOP LEFT AND TOP RIGHT OF THE SCREEN. HOWEVER, SOME OF THE SEGMENTS WERE FLASHING. THE REPORTER ALLEGED SHE COULD NOT READ ANY NUMBERS AS SHE ONLY SEES SEGMENTS THAT WEARE PART OF THE NUMBERS. THERE WAS NO ALLEGATION OF AN ACTUAL RESULT MISINTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371908 ↗
• MalfunctionDec 11, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER STATED THEY HAD AN ISSUE WITH THE DISPLAY OF A COAGUCHEK METER. THE CUSTOMER CHANGED THE METER BATTERIES TWICE BUT WAS UNABLE TO SELECT THE METER SETTINGS. THE DISPLAY DID NOT APPEAR TO BE CORRECT. THE CUSTOMER PERFORMED A DISPLAY CHECK AND ALL SEGMENTS WERE COMPLETE AND READABLE. WHEN THE CUSTOMER LET GO OF THE "I" BUTTON, ONLY "AM/PM", AN HOURGLASS, THE WORD "SET", AND A TEST STRIP WITH A CHECK MARK WERE OBSERVED ON THE DISPLAY. WHEN CHECKING RESULTS FROM THE METER'S MEMORY, A SINGLE "8", A BLOOD DROP, THE WORDS "ERROR", "MEM", "TIME", AND THE METER ICON WERE DISPLAYED. THE CUSTOMER WAS UNABLE TO SEE THE MOST RECENT TEST RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306292 ↗
• MalfunctionNov 29, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION ABOUT AN ODD DISPLAY WHEN THE PATIENT TRIED TO TEST ON A COAGUCHEK XS METER. THE PATIENT'S HUSBAND ALLEGED THAT ONCE HE RELEASED THE POWER BUTTON, THE METER SHOWED A FLASHING STRIP ICON AND < RRR SEC IN THE RESULTS FIELD WITH THE TIME AND DATE ABOVE IT. THE PATIENT'S HUSBAND STATED THE DISPLAY ISSUE BEGAN ON 28-OCT-2023 WHEN THE PATIENT RAN A TEST WHICH RESULTED IN 1.6 INR AND BELIEVED TO BE LOW. THE DISPLAY APPEARED DIM AT THAT TIME TOO. REPORTEDLY, THE PATIENT'S WARFARIN DOSAGE WAS INCREASED BASED ON THE METER RESULT OF 1.6 INR ON 28-OCT-2023. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228698 ↗
• MalfunctionNov 28, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK XS METER. THE CUSTOMER STATED THAT PART OF THE DISPLAY SCREEN WAS NOT LIGHTING UP; IT APPEARED TO BE FADING. UPON COMPLETION OF A DISPLAY CHECK, ONLY PART OF THE DISPLAY SEGMENTS WERE VISIBLE. THE CUSTOMER STATED THE BOTTOM HALF OF THE DISPLAY SCREEN WAS FADED AND THE BOTTOM HALF OF THE RESULTS FIELD WAS FADED AND NOT BRIGHT LIKE THE UPPER HALF OF THE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217349 ↗
• MalfunctionNov 27, 2023Off-Label Use; Off-Label Use

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE ON A COAGUCHEK XS METER. THE DATE OF THE EVENT IS AN APPROXIMATION; THE PATIENT COULD NOT SPECIFY WHEN THE DISPLAY ISSUE BEGAN. THE PATIENT ALLEGED THE DISPLAY SCREEN HAD BEEN FADING "FOR QUITE SOME TIME" AND IT WAS HARD TO READ THE RESULTS. UPON COMPLETION OF A DISPLAY CHECK, THE SEGMENTS OF THE RESULTS FIELD WERE PRESENT, HOWEVER, THE PATIENT ALLEGED THEY HAVE TO HOLD THE METER BACK AT AN ANGLE TO SEE THE "8"S. THE METER MEMORY WAS REVIEWED AND THE LAST RESULT WAS 2.2 INR. THE PATIENT ALLEGED IT WAS "A STRUGGLE" TO SEE THE RESULT. THE PATIENT ALLEGED WHEN HE ATTEMPTED TO TEST ON (B)(6) 2023 THE DISPLAY WAS TOO LIGHT TO SEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210768 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Non Reproducible Results; Adverse Event Without Identified Device or Use Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER: (B)(6) COMPARED TO A LABORATORY RESULT USING AN UNKNOWN METHOD. THE METER RESULT WAS 1.8 INR. THE METER RESULT WITHIN 4 HOURS WAS 2.4 INR. NO MEDICATION CHANGES WERE MADE BASED ON THE METER RESULTS. THE PATIENT¿S THERAPEUTIC RANGE IS 2.5 - 3.0INR. THE PATIENT'S TESTING FREQUENCY IS WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194167 ↗
• MalfunctionNov 9, 2023Image Display Error/Artifact; Battery Problem; Image Display Error/Artifact; Battery Problem

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK XS METER. THE METER DISPLAYS SIX MARKS ACROSS THE RESULTS FIELD. THE REPORTER ALLEGED THE MARKS "LOOK LIKE A SPEAKER BUT IT IS GOING ACROSS THE RESULTS FIELD". A DISPLAY CHECK WAS PERFORMED AND THE MARKS WERE PRESENT IN THE RESULTS FIELDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103434 ↗
• MalfunctionNov 7, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF DISPLAY ISSUE ON A COAGUCHEK XS METER. THE PATIENT STATED THAT THE METER WAS POWERING OFF AFTER PRESSING THE M BUTTON AND THAT THE SCREEN DISPLAYED LOTS OF ICONS BEFORE GOING BLANK. A DISPLAY CHECK WAS PERFORMED AND THE PATIENT STATED THAT THE SEGMENTS WERE BLURRY AND HARD TO SEE. THERE WAS NO ALLEGATION OF MISINTERPRETED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084201 ↗
• MalfunctionOct 30, 2023Mechanical Problem; Mechanical Problem

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK METER. THE REPORTER STATED THAT THE METER MEMORY AND SEGMENTS WERE FADED. THE REPORTER REPLACED THE BATTERIES AND STATED THAT HE COULD BARELY SEE THE NUMBERS IN THE TOP RIGHT. DURING THE CALL, A DISPLAY CHECK WAS PERFORMED AND THE REPORTER STATED THAT AT FIRST HE COULD SEE EVERYTHING BUT THE SEGMENTS AND THREE 8'S IN THE MIDDLE BEGAN TO FADE. THE METER MEMORY WAS ALSO CHECKED. THE REPORTER STATED THAT HE CAN SEE THE "MEM" ON THE LEFT AND THE "0" ON THE RIGHT BUT THE THREE DASHES IN THE MIDDLE WERE FADED. THE REPORTER STATED THAT THERE WAS NO CORROSION IN THE BATTERY COMPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028327 ↗
• MalfunctionOct 20, 2023Display Difficult to Read; No Display/Image; Activation Problem; Display Difficult to Read; No Display/Image; Activation Problem

  WE RECEIVED AN ALLEGATION ABOUT A DISPLAY ISSUE ON A COAGUCHEK XS METER. THE PATIENT ALLEGED THAT THE METER TURNED ON WITH A FADED DISPLAY TOO FAINT TO READ THEN IT TURNED OFF. HE REPLACED THE BATTERIES WITH NEW ONES. THE PATIENT WASN'T ABLE TO RUN A TEST AS THE METER DID NOT POWER BACK ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976556 ↗
• MalfunctionOct 19, 2023Display Difficult to Read; Device Difficult to Setup or Prepare; Display Difficult to Read; Device Difficult to Setup or Prepare

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE ON A COAGUCHEK XS METER. DURING A DISPLAY CHECK FOR RESULTS IN THE METER MEMORY, THE CUSTOMER ALLEGED THE DISPLAY WAS FADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966154 ↗
• MalfunctionOct 11, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE DISPLAY OF THE COAGUCHEK XS METER. THE CUSTOMER CHANGED THE BATTERIES AND THE METER POWERS ON BUT THE SEGMENTS ARE FLICKERING AND ARE FADED. THE CUSTOMER DESCRIBED VERTICAL LINES IN THE RESULT FIELD. THE CUSTOMER WAS UNABLE TO ACCESS THE METER MEMORY OR PERFORM A DISPLAY CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914693 ↗
• MalfunctionOct 4, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION ABOUT A COAGUCHEK XS METER DISPLAYING THE INCORRECT CHIP CODE NUMBER. THE PATIENT ALLEGED THAT THE METER FLICKERED DIFFERENT CODE NUMBERS (116 AND THEN 115) BACK AND FORTH DURING THE SAME STRIP INSERTION. THE PATIENT DETERMINED THAT THE CHIP CODE KEY INSERTED IN THE METER WAS 106. ON THE CALL, A DISPLAY TEST WAS PERFORMED AND THE DISPLAY APPEARED TO BE COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868356 ↗
• MalfunctionOct 2, 2023Image Display Error/Artifact; No Device Output; Image Display Error/Artifact; No Device Output

  WE RECEIVED AN ALLEGATION ABOUT A COAGUCHEK XS METER HAVING A FADED DISPLAY AND NOT DETECTING THE TEST STRIPS. THE REPORTER STATED THAT THEY HAD TO TILT THE METER IN ORDER TO SEE EVERYTHING ON THE DISPLAY BECAUSE IT WAS FADED. THE REPORTER ALSO CONFIRMED THAT NO HARM OCCURRED IN RELATION TO THE DISPLAY ISSUES BECAUSE THE METER HAD NOT BEEN IN USE SINCE THE ISSUES BEGAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853940 ↗
• MalfunctionSep 26, 2023Display Difficult to Read; Image Display Error/Artifact; Display Difficult to Read; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). THE CUSTOMER STATED THE METER DISPLAY IS FAINT AND DIFFICULT TO READ. THERE WAS NO MISINTERPRETATION OF RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817240 ↗
• MalfunctionSep 13, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A METER DISPLAY ISSUE ON A COAGUCHEK XS METER, SERIAL NUMBER (B)(6). THE CUSTOMER ALLEGED THAT THE METER DISPLAY IS FADED EVEN AFTER CHANGING THE BATTERIES AND THAT THE FIRST NUMBER IN THE METER MEMORY AND THE COUNTDOWN ARE MISSING SEGMENTS. THE CUSTOMER PERFORMED A DISPLAY CHECK AND THEY STATED THEY SEE A FLASHING STRIP BUT NOT MUCH ELSE. THERE WAS NO ALLEGATION OF MISINTERPRETED RESULTS DUE TO THE DISPLAY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740630 ↗
• MalfunctionSep 8, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). METER DISPLAY HAS SEGMENTS THAT APPEAR FAINT AND ARE HARD TO SEE. THE DISPLAY WAS CHECKED AND SEVERAL SEGMENTS WERE LIGHTER AND HARDER TO READ. NO MISINTERPRETATION OF RESULTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711792 ↗
• MalfunctionSep 5, 2023Circuit Failure; Misassembly by Users; Circuit Failure; Misassembly by Users

  WE RECEIVED AN ALLEGATION OF A BURNT BATTERY CONTACT ON COAGUCHEK XS METER SERIAL NUMBER (B)(4). CUSTOMER STATED THE BATTERY COMPARTMENT CONTAINS ONE BATTERY CONTACT THAT APPEARS BURNT. THE CUSTOMER STATES THE BURNT APPEARANCE MAKES THEM THINK THE METER SUFFERED AN ELECTRICAL SHORT. METER NO LONGER POWERS ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683825 ↗
• MalfunctionJul 19, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER, SERIAL NUMBER (B)(6), COMPARED TO A LABORATORY RESULT USING AN UNKNOWN METHOD. AT 7:00 A.M., THE LABORATORY RESULT WAS 2.5 INR. AT 9:00 A.M., THE METER RESULT WAS 1.5 INR. NO MEDICATION CHANGES WERE MADE BASED ON THE METER RESULT. THE PATIENT¿S THERAPEUTIC RANGE IS 2.5 - 3.0 INR. THE PATIENT'S TESTING FREQUENCY IS WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356588 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062925. One submission often covers many models, so check the product and lot details in each record.

• Z-0804-2021 · Dec 2, 2020 · Terminated
  CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 048
• Z-1581-2013 · May 16, 2013 · Terminated
  CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking antic
• Z-2003-2009 · Jul 22, 2009 · Terminated
  Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point
• Z-1594-2009 · May 13, 2009 · Terminated
  Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche