CoaguChek XS Professional Use Care Kit 4837975001Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00365702126107), received between Oct 11, 2018 and Oct 25, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (9 reports).

3 other recalls cover devices cleared under the same FDA submission (K060978); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK XS METER. THE METER DISPLAY HAS 6 HORIZONTAL LINES ON THE DISPLAY THAT IMPACT THE RESULTS FIELD. THE RESULTS FIELD IS ALSO FADED. THERE WAS NO MISINTERPRETATION OF RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007055 ↗
• MalfunctionJul 6, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A SCREEN DISPLAY ISSUE ON A COAGUCHEK XS PRO METER, SERIAL NUMBER (B)(6). THE CUSTOMER STATED THAT THEY HAD RECEIVED AN ERROR 8 ON THE METER AND THAT IT WAS FLICKERING IN THE RESULTS FIELD. PER PRODUCT LABELING, "ERROR: INTERNAL ERROR ERROR DURING THE INTERNAL CHECKS WHICH THE METER PERFORMS. SOLUTION: POWER THE METER OFF AND REMOVE THE BATTERIES. WAIT AT LEAST ONE MINUTE BEFORE RE-INSERTING THE BATTERIES IN THE BATTERY COMPARTMENT, AND THEN SET THE DATE AND TIME AS DESCRIBED IN THE METER SET-UP SECTION OF THIS MANUAL. REPEAT THE TEST. IF THE ERROR MESSAGE PERSISTS, THE METER HAS A DEFECT. CONTACT YOUR ROCHE REPRESENTATIVE." THE CUSTOMER REPLACED THE BATTERIES BUT THE ERROR 8 PERSISTED. THERE WAS NO MISINTERPRETATION OF RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270329 ↗
• MalfunctionJun 30, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK XS METER. THE REPORTER STATED THAT THERE WERE FADED SEGMENTS IN THE RESULTS FIELD. A DISPLAY CHECK WAS PERFORMED AND IT WAS NOTED THAT THE GREATER THAN SYMBOL, THE LEFT AND RIGHT SIDES OF THE TOP CIRCLE OF THE "8'S", AND THE "%Q" WERE ALL FADED. THE METER MEMORY WAS CHECKED AND THE "MEM" AND "INR" WERE FADED ALONG WITH THE "1" OF THE "1.6" RESULT ON THE SCREEN. IT WAS CONFIRMED THAT THERE WAS NO MISINTERPRETATION OF RESULTS DUE TO THE DISPLAY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239824 ↗
• MalfunctionFeb 3, 2023Display Difficult to Read; Display Difficult to Read

  THERE WAS AN ALLEGATION OF A SCREEN DISPLAY ISSUE ON A COAGUCHEK XS PROFESSIONAL METER. THE CUSTOMER ALLEGED THAT THERE WERE SEGMENTS MISSING IN THE RESULTS FIELD ON THE FAR RIGHT AND WHERE THE TIME IS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295646 ↗
• MalfunctionDec 27, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A SCREEN DISPLAY ISSUE ON A COAGUCHEK XS PRO METER. IT WAS REPORTED THAT THERE WERE SEGMENTS MISSING FROM THE 8S IN THE DISPLAY AREA AND THE DISPLAY IS FADING IN AND OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052379 ↗
• MalfunctionOct 31, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER STATED THEY HAD A DISPLAY ISSUE WITH A COAGUCHEK XS METER. UPON COMPLETION OF A DISPLAY CHECK, SEGMENTS WERE MISSING FROM THE RESULTS FIELD OF THE DEVICE. NO PATIENTS HAVE BEEN TESTED WITH THE METER SINCE THE CUSTOMER NOTICED THE MISSING SEGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700489 ↗
• MalfunctionJan 18, 2022Display Difficult to Read; Display Difficult to Read

  THE INITIAL REPORTER COMPLAINED OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). CUSTOMER STATES 989 APPEARS IN THE UPPER LEFT HAND CORNER ON THE METER. THE 989 LOOKS FADED AND THEN COMPLETELY FADES OUT OF THE DISPLAY. THERE WAS NO ALLEGATION THAT ANY TEST RESULTS HAD BEEN MISINTERPRETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281906 ↗
• MalfunctionNov 23, 2021Display Difficult to Read; Display Difficult to Read

  THE INITIAL REPORTER HAD AN ISSUE WITH THE METER DISPLAY WITH A COAGUCHEK XS METER. THE REPORTER STATED THE RESULT FIELD OF THE METER WAS FADED. A DISPLAY CHECK WAS ATTEMPTED AND THE REPORTER WAS NOT ABLE TO GET A FULL DISPLAY ON THE SCREEN. THE REPORTER ENTERED THE METER MEMORY AND COULD SEE THE LAST RESULT OF 2.2 INR BUT THE RESULT WAS FADED. THERE WAS NO MISINTERPRETATION OF ANY RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861852 ↗
• MalfunctionNov 7, 2021Display Difficult to Read; Display Difficult to Read

  THE INITIAL REPORTER COMPLAINED OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). CUSTOMER STATED THE FIRST TWO EIGHTS IN THE RESULTS FIELD APPEAR FADED. THE FADED DISPLAY DID NOT CAUSE A MISINTERPRETATION OF RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758357 ↗
• MalfunctionAug 26, 2021Display Difficult to Read; Display Difficult to Read

  THE INITIAL REPORTER COMPLAINED OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE CUSTOMER STATED WHEN A TEST STRIP IS INSERTED INTO THE DEVICE, THE CODE NUMBER DISPLAYED, BUT IT WAS FADED AND THE MIDDLE NUMBER WAS HARD TO READ. THE CODE NUMBER MAKES UP THE SEGMENTS OF THE RESULTS FIELD. THIS ISSUE COULD CAUSE THE MISINTERPRETATION OF TEST RESULTS. THERE WAS NO ALLEGATION THAT ANY TEST RESULTS HAD BEEN MISINTERPRETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369452 ↗
• MalfunctionAug 12, 2021Circuit Failure; Circuit Failure

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK XS METER. THE REPORTER STATED THE METER WOULD CONTINUALLY RESET OR GIVE AN ERROR. WHEN THE METER DID DISPLAY A RESULT, THE RESULT COULD NOT BE READ BECAUSE THE SCREEN ONLY PARTIALLY LIGHTS UP. UPON COMPLETION OF A DISPLAY CHECK, THE REPORTER SAW 666 INSTEAD OF 888. THE METER MEMORY WAS REVIEWED AND THE REPORTER SAW WHAT LOOKED TO BE 45.5 SEC BUT WAS UNABLE TO SEE THE DATE. NO RESULTS WERE MISINTERPRETED DUE TO THE DISPLAY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312889 ↗
• MalfunctionAug 12, 2021Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER HAD AN ISSUE WITH THE METER DISPLAY ON COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE REPORTER STATED THE METER IS NOT POWERING PROPERLY. THE REPORTER CAN SEE A PARTIAL DISPLAY AND THEN THE METER GOES BLANK. THE REPORTER STATED THE METER BEEPS 3 TIMES BUT DOES NOT DISPLAY ANY ICONS. THE REPORTER PERFORMED A DISPLAY CHECK AND ADVISED PARTIAL DISPLAY APPEARS MOMENTARILY AND THE METER GOES BLANK. THE REPORTER CLEANED THE CONTACTS AND INSTALLED NEW BATTERIES. THE METER DOES NOT POWER ON AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311740 ↗
• MalfunctionJul 19, 2021Display Difficult to Read; Display Difficult to Read

  THE INITIAL REPORTER COMPLAINED OF A DISPLAY ISSUE WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). CUSTOMER PERFORMED A FULL DISPLAY CHECK AND THE RESULTS FIELD IS FLICKERING. THE MEMORY WAS ACCESSED AND THE RESULTS FIELD IS FLICKERING IN THE MEMORY. THERE WAS NO ALLEGATION THAT ANY TEST RESULTS HAD BEEN MISINTERPRETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191732 ↗
• MalfunctionNov 6, 2018Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER COMPLAINED OF ISSUES WITH TWO OF THEIR COAGUCHEK XS METERS THAT MAY IMPACT THE INTERPRETATION OF THEIR RESULTS. THIS MEDWATCH WILL COVER THE METER WITH SERIAL NUMBER (B)(4). FOR INFORMATION ON THE METER WITH SERIAL NUMBER (B)(4) PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE CUSTOMER INITIALLY COMPLAINED THAT THE METER SCREEN WAS SHAKY. A DISPLAY CHECK WAS PERFORMED AND THERE WERE MISSING SEGMENTS THAT COULD AFFECT THE INTERPRETATION OF RESULTS. THERE WAS NO ALLEGATION OF ERRONEOUS RESULTS OR AN ADVERSE EVENT. THERE WAS NO INFORMATION PROVIDED TO REASONABLY SUGGEST THAT THERE WAS ANY ACTUAL MISINTERPRETATION OF RESULTS. THE METER WAS RETURNED FOR FURTHER INVESTIGATION. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041214 ↗
• MalfunctionNov 6, 2018Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER COMPLAINED OF ISSUES WITH TWO OF THEIR COAGUCHEK XS METERS THAT MAY IMPACT THE INTERPRETATION OF THEIR RESULTS. THIS MEDWATCH WILL COVER THE METER WITH SERIAL NUMBER (B)(4). FOR INFORMATION ON THE METER WITH SERIAL NUMBER (B)(4) PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE METER INITIALLY HAD NO POWER. THE CUSTOMER REPLACED THE BATTERIES AND PERFORMED A DISPLAY CHECK. MISSING SEGMENTS WERE NOTED DURING THE DISPLAY CHECK WHICH COULD AFFECT THE INTERPRETATION OF RESULTS. THERE WAS NO ALLEGATION OF ERRONEOUS RESULTS OR AN ADVERSE EVENT. THERE WAS NO INFORMATION PROVIDED TO REASONABLY SUGGEST THAT THERE WAS ANY ACTUAL MISINTERPRETATION OF RESULTS. THE METER WAS RETURNED FOR FURTHER INVESTIGATION. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041175 ↗
• MalfunctionOct 11, 2018Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER COMPLAINED OF AN ISSUE WITH THEIR COAGUCHEK XS METER SERIAL NUMBER (B)(4) THAT MAY IMPACT THE INTERPRETATION OF THEIR RESULTS. THE CUSTOMER INITIALLY STATED THAT THEIR METER DISPLAY APPEARED FADED OUT. THE CUSTOMER CHANGED THE BATTERIES BUT THE ISSUE REMAINED. THE CUSTOMER PERFORMED A DISPLAY CHECK AND STATED THE DISPLAY WAS NOT COMPLETE AND THERE WERE SEGMENTS MISSING. THE CUSTOMER STATED THAT THE METER HAS NOT BEEN USED FOR TESTING SINCE THE DISPLAY STARTED TO LOOK DIFFERENT. THERE WAS NO ALLEGATION OF ERRONEOUS RESULTS OR AN ADVERSE EVENT. THERE WAS NO INFORMATION PROVIDED TO REASONABLY SUGGEST THAT THERE WAS ANY ACTUAL MISINTERPRETATION OF RESULTS. THE METER WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955352 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060978. One submission often covers many models, so check the product and lot details in each record.

• Z-0803-2021 · Dec 2, 2020 · Terminated
  CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975
• Z-1584-2013 · May 16, 2013 · Terminated
  CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin
• Z-2002-2009 · Jul 22, 2009 · Terminated
  Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus Sy