CoaguChek XS Plus Professional Care Kit 5021537001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00365702164109), received between Aug 1, 2018 and Feb 9, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (6 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, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2023No Device Output; No Device Output

  WE RECEIVED AN ALLEGATION OF AN INTERMITTENT DISPLAY ISSUE ON A COAGUCHEK XS PLUS METER. THE CUSTOMER ALLEGES THAT THE METER WILL DISPLAY AN INR RESULT FOR A FEW SECONDS AFTER RUNNING A TEST AND THEN THE RESULT WILL DISAPPEAR AND THE METER RETURNS TO THE MAIN MENU. THE HOURGLASS WILL THEN REAPPEAR ON THE DISPLAY SCREEN. NONE OF THE RESULTS FROM THIS ISSUE WERE LOCATED IN THE METER MEMORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16333160 ↗
• MalfunctionOct 25, 2022Display or Visual Feedback Problem; No Device Output; Display or Visual Feedback Problem; No Device Output

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE COAGUCHEK XS PLUS USER INTERFACE. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN AND STARTED OCCURRING APPROXIMATELY ON (B)(6) 2022. THE REPORTER STATED THE METER NO LONGER ASKS FOR THE OPERATOR ID. ADDITIONALLY, WHEN A PATIENT ID IS ENTERED, THE METER WILL START TYPING LETTERS ON ITS OWN, EVEN WHEN THE OPERATOR IS NOT PRESSING ANYTHING ON THE SCREEN. NO DISCREPANCIES WERE OBSERVED UPON METER POWER UP AND THE DISPLAY IS COMPLETE. THE REPORTER TRIED ACCESSING THE METER SET UP TO VERIFY WHETHER THE OPERATOR ID IS DISABLED. THE METER POPULATED AN ADMINISTRATOR BOX AND REQUESTED A PASSWORD. THE REPORTER WAS PROVIDED THE PASSWORD OF THE DAY, BUT THE METER REJECTED THE PASSWORD. FURTHER ATTEMPTS TO ENTER A PASSWORD WERE NOT SUCCESSFUL. THE REPORTER WAS INSTRUCTED TO ACCESS THE MAIN MENU AND ACCESS "PATIENT TEST". THE REPORTER WAS ABLE TO ENTER VARIOUS LETTERS AND ALL LETTERS SELECTED BY THE REPORTER WERE ENTERED. THE TYPING ISSUE COULD NOT BE RECREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670669 ↗
• MalfunctionOct 14, 2022Image Display Error/Artifact; Audible Prompt/Feedback Problem; Image Display Error/Artifact; Audible Prompt/Feedback Problem

  WE RECEIVED AN ALLEGATION ABOUT A DARK SCREEN ON A COAGUCHEK XS PLUS METER. IT WAS REPORTED THAT THE METER SCREEN IS TOO DARK TO CLEARLY READ OR INTERPRET THE RESULTS. THE SCREEN CONTRAST WAS INCREASED FROM 8 TO 10 BUT IS STILL TOO DARK TO READ. WHEN THE METER IS PLACED INTO THE BASE UNIT, THE RESULTS ARE STILL UPLOADED TO THE DMS SYSTEM. NO RESULTS HAVE BEEN MISINTERPRETED DUE TO THE DARK SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15609070 ↗
• MalfunctionSep 9, 2022Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH 3 COAGUCHEK XS METERS. THIS MDR IS FOR METER #3. THE METER HAS BLACK LINES ON THE SCREEN. THE REPORTER DESCRIBED THE SCREEN AS "SIMILAR TO AN OLD TV". IT WAS VERIFIED THAT THE LINES WOULD INTERFERE WITH THE INTERPRETATION OF RESULTS. NO MISINTERPRETATION OF RESULTS WAS REPORTED. REFER TO MDR WITH PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF METER #1 AND MDR WITH PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF METER #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394428 ↗
• MalfunctionSep 9, 2022Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH 3 COAGUCHEK XS METERS. THIS MDR IS FOR METER #1. THE METER WOULD POWER ON, BRIEFLY FLASH A WHITE SCREEN, AND THEN A BLACK SCREEN. NO MISINTERPRETATION OF RESULTS WAS REPORTED. REFER TO MDR WITH - PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF METER #2 AND MDR - PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF METER #3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394402 ↗
• MalfunctionSep 9, 2022Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH 3 COAGUCHEK XS METERS. THIS MDR IS FOR METER #2. THE METER HAS BLACK LINES ON THE SCREEN. THE REPORTER DESCRIBED THE SCREEN AS "SIMILAR TO AN OLD TV". IT WAS VERIFIED THAT THE LINES WOULD INTERFERE WITH THE INTERPRETATION OF RESULTS. NO MISINTERPRETATION OF RESULTS WAS REPORTED. REFER TO MDR WITH PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF METER #1 AND MDR WITH PATIENT IDENTIFIER (B)(6) FOR THE INVESTIGATION OF METER #3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394352 ↗
• MalfunctionAug 25, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER STATED THEY HAD A DISPLAY ISSUE WITH A COAGUCHEK XS PLUS METER SERIAL NUMBER (B)(4). THE METER DISPLAY HAS FADED SEGEMENTS. METER DISPLAYS THE ROCHE LOGO WHEN POWERED ON BUT THE REST OF THE DISPLAY HAS BLACK AND WHITE SQUIGGLES ON IT. NO MISINTERPRETATION OF RESULTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294568 ↗
• MalfunctionJun 28, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE DISPLAY OF COAGUCHEK XS PLUS METER SERIAL NUMBER (B)(4). THE METER HAD SEGMENTS THAT WERE MISSING FROM THE RESULTS FIELD OF THE DISPLAY. THE ISSUE IMPEDED THE CUSTOMER'S ABILITY TO READ THE RESULTS FIELD OF THE DISPLAY. IT WAS NOTED THERE WERE LINES ON THE DISPLAY AND RAINBOW LIKE COLORS ALSO APPEARED ON THE DISPLAY. THE FACILITY HAS NOT MIS-REPORTED RESULTS DUE TO THE ISSUE. THE METER HAS NOT BEEN USED SINCE THE ISSUE WAS NOTICED. THE BATTERY COMPARTMENT OF THE METER WAS NOT SOILED AND THE CUSTOMER HAS NOTED THERE WAS NO MISUSE OF THE METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840183 ↗
• MalfunctionSep 21, 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 METER DISPLAY IS BLACK WITH A BIT OF BLUE AT THE BOTTOM OF THE SCREEN. CUSTOMER STATED THE ISSUE COULD IMPEDE THE ABILITY TO READ THE RESULTS. THERE WAS NO ALLEGATION THAT ANY TEST RESULTS HAD BEEN MISINTERPRETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507757 ↗
• MalfunctionAug 1, 2018Unauthorized Access to Computer System; Unauthorized Access to Computer System

  AN INTERNAL INVESTIGATION HAS DETERMINED THAT COAGUCHEK XS PLUS METERS ARE VULNERABLE TO A CYBERSECURITY OR DATA BREACH. THIS WAS DISCOVERED DURING ROCHE INTERNAL INVESTIGATIONS IN CONJUNCTION WITH A CYBERSECURITY CONSULTANT. THE INTERNAL INVESTIGATION DETERMINED THAT SIGNIFICANT PRODUCT AND CYBERSECURITY KNOWLEDGE IS NEEDED TO EXPLOIT THESE VULNERABILITIES. THE CONSULTANT WAS ABLE TO REVERSE ENGINEER THE SERVICE PASSWORD GENERATOR. THE CONSULTANT WAS ALSO ABLE TO EXECUTE CODE THROUGH A HIDDEN COMMAND. THE INVESTIGATION DETERMINED THE FOLLOWING: DELETION OF PROTECTED HEALTH INFORMATION MAY BE POSSIBLE. MODIFICATION OF PROTECTED HEALTH INFORMATION MAY BE POSSIBLE. CHANGING THE UNITS OF MEASURE MAY BE POSSIBLE. THE VULNERABILITIES CAN BE EXPLOITED INDEPENDENTLY OR IN COMBINATION. IN THE WORST CASE SCENARIO, THE MEDICAL RISK IS HIGH. THE PROBABILITY OF THIS TYPE OF EVENT OCCURRING IS LOW (CRIMINAL INTENT, THEFT OF THE DEVICE, ENTERING THE FIREWALL, ETC.). THE LIKELIHOOD OF OCCURRENCE OF A SUCCESSFUL ATTACK IS DEEMED LOW TO THEORETICAL WITH INSTALLATIONS SECURED IN ACCORDANCE WITH ROCHE CYBER SECURITY RECOMMENDATIONS. THERE HAVE BEEN NO REPORTS OF ACTUAL OCCURRENCE IN THE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740425 ↗