CoaguChek Vantus System 07729952160Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00365702700499), received between Jul 14, 2021 and Sep 16, 2025 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K170960); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Device Difficult to Setup or Prepare; High Test Results; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; High Test Results; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE INR RESULT FOR ONE PATIENT TESTED WITH THE COAGUCHEK VANTUS USA METER COMPARED TO AN UNKNOWN LABORATORY METHOD. THE LABORATORY RESULT AT 4:13 PM WAS 2.97 INR. THE METER RESULT AT 5:56 PM WAS 4.2 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.5 TO 3.5 INR.

  Patient problems: Dizziness; Headache; Nausea

  MAUDE report 23061942 ↗
• MalfunctionDec 21, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK VANTUS METER. THE PATIENT ALLEGED HALF OF THE DISPLAY IS WHITE AND BLACK WITH RED LINES AND THE OTHER HALF OF THE DISPLAY HAS PARTIAL WORDS THAT ARE NOT CLEAR. THERE WAS NO ALLEGATION OF A RESULT MISINTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374688 ↗
• InjuryNov 29, 2023Circuit Failure; No Device Output; High Test Results; Adverse Event Without Identified Device or Use Problem; Circuit Failure; No Device Output; High Test Results; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED AN ALLEGATION THAT A PATIENT WAS UNABLE TO TEST ON THEIR COAGUCHEK XS METER BETWEEN (B)(6) 2023 AND (B)(6) 2023 WHICH MAY HAVE LED TO THE HOSPITALIZATION AND TREATMENT FOR VITAMIN K. THE PATIENT REPORTEDLY ATTEMPTED TO TEST SEVERAL TIMES BETWEEN (B)(6) 2023 AND (B)(6)2023 AND RECEIVED ERROR M-44 ON THE METER. ON (B)(6) 2023 AT 10:42 AM THE PATIENT REPORTEDLY TESTED AGAIN AND RECEIVED A METER RESULT OF 4.9 INR. AROUND 4 PM THE PATIENT ALLEGEDLY WENT TO THE EMERGENCY ROOM DUE TO NOT FEELING WELL AND HAVING A KNOT IN HIS PELVIS. THE PATIENT'S LABORATORY RESULT WAS REPORTED TO BE HIGH. THE PATIENT HAD A BRUISE ON HIS ABDOMEN AND WAS DIAGNOSED WITH AN INTERNAL PELVIC BLEED. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS. THE PATIENT WAS ALLEGEDLY TREATED WITH AN INTRAVENOUS VITAMIN K. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.5 INR AND THE INTERVAL OF TESTING WAS WEEKLY.

  Patient problems: Easy Bruising

  MAUDE report 18231499 ↗
• MalfunctionNov 20, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH COAGUCHEK VANTUS METER SERIAL NUMBER (B)(6). THE LEFT SIDE OF THE METER DISPLAY IS FAINT AND THE RIGHT SIDE IS WHITE. THE CUSTOMER IS ABLE TO NAVIGATE THE MENUS AND USE THE METER DESPITE THE DISPLAY ISSUE. THE DISPLAY BEING FAINT ON ONE SIDE AND WHITE ON THE OTHER MAKES THE RESULT DIFFICULT TO READ. NO MISINTERPRETATION OF RESULTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170174 ↗
• MalfunctionOct 13, 2023Image Display Error/Artifact; Adverse Event Without Identified Device or Use Problem; Image Display Error/Artifact; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK VANTUS METER. THE USER ALLEGED THE DISPLAY "LOOKS LIKE GREEN CHRISTMAS TREE" AND HAD SOME COLORED LINES BUT NOTHING ELSE. THE METER ALLEGEDLY DID NOT HAVE THE MAIN MENU DISPLAYED AND THE USER WAS UNABLE TO PERFORM A DISPLAY CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930556 ↗
• MalfunctionApr 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS ALLEGED THAT THERE WAS AN ISSUE WITH THE DISPLAY OF COAGUCHEK VANTUS METER SERIAL NUMBER (B)(4). THE CUSTOMER COULD NOT CLEARLY SEE THE RESULTS IN THE RESULTS FIELD OF THE METER DISPLAY. A COLOR DISPLAY TEST WAS PERFORMED ON THE METER AND IT DISPLAYED THE COLORS AS IT SHOULD. THE CUSTOMER ADVISED SHE SAW SIX NUMBERS ACROSS THE SCREEN, SUCH AS "62489" AND THAT IT WAS NOT SHOWING HER INR RESULT. AT AROUND 2:00 P.M. ON (B)(6) 2023, THE CUSTOMER MEASURED A VALUE OF 2.6 INR ON THE METER. WHEN CHECKING THE METER'S PATIENT RESULT MEMORY, THIS VALUE WAS NOT OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744788 ↗
• InjuryFeb 9, 2023Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED AN ALLEGATION THAT THE COAGUCHEK VANTUS METER MAY HAVE CONTRIBUTED TO A PATIENT'S GASTROINTESTINAL (GI) BLEEDING. THE REPORTER INITIALLY CALLED BECAUSE THE METER WAS ALLEGEDLY NOT WORKING AND THE NURSE WAS UNABLE TO COMPLETE THE TEST. THE METER LOG WAS CHECKED AND THE FOLLOWING ERRORS WERE NOTED: M-42, M-26, E-68, AND M-31. DURING THE CALL, THE REPORTER ALSO MENTIONED THAT THE PATIENT WAS JUST RECENTLY RELEASED FROM THE HOSPITAL DUE TO GI BLEEDING. THE LAST METER RESULT PRIOR TO THE ALLEGED GI BLEEDING WAS ON (B)(6) 2022. THE METER RESULT ON (B)(6) 2022 FROM THE METER MEMORY WAS REPORTED TO BE > 6.0 INR. THE PATIENT REPORTEDLY SKIPPED WARFARIN FOR 3 DAYS "AND THEN HALF A PILL" BASED ON THIS RESULT. THE REPORTER STATED THAT THE PATIENT DID NOT TEST ON THE METER IN (B)(6) 2022 AND ALSO DID NOT HAVE HOME HEALTH DO TESTS ON THE METER. THE REPORTER STATED THAT THE PATIENT HAD HOME HEALTH DO A VENOUS DRAW TO TEST INR IN (B)(6) 2022, BUT DID NOT RECEIVE RESULTS UNTIL AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE REPORTER STATED THAT ON (B)(6) 2022, THE PATIENT WAS VERY PALE AND HAD A BLACK BOWEL MOVEMENT. THE PATIENT REPORTEDLY HAD IRON AND "PEPTO" WHICH THE REPORTER STA

  Patient problems: Anemia; Gastrointestinal Hemorrhage; Insufficient Information

  MAUDE report 16344562 ↗
• MalfunctionJan 13, 2023No Device Output; No Device Output

  WE RECEIVED AN ALLEGATION OF ERROR M-44 FOR 1 PATIENT TESTED WITH 4 DIFFERENT COAGUCHEK VANTUS METERS SERIAL NUMBERS (B)(4). AN INTERFERENCE WAS SUSPECTED. ON (B)(6) 2022 THE PATIENT HAD AN ERROR M-44 WHEN TESTING ON COAGUCHEK VANTUS METER SERIAL NUMBER (B)(4) WITH TEST STRIPS LOT NUMBER 62216021. ON (B)(6) 2022 THE PATIENT HAD AN ERROR M-44 WHEN TESTING ON COAGUCHEK VANTUS METERS SERIAL NUMBERS (B)(4) WITH TEST STRIPS LOT NUMBER 63657521. THE PATIENT STATED HER DOCTOR USED A COAGUCHEK XS METER AND WAS ABLE TO TEST HER WITH THEIR XS METER AND TEST STRIPS WITHOUT GETTING AN ERROR. THE PATIENT'S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158603 ↗
• MalfunctionDec 13, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER COMPLAINED OF A DISPLAY ISSUE WITH COAGUCHEK VANTUS METER SERIAL NUMBER (B)(4). THE CUSTOMER STATES THE METER DISPLAY GETS DIM AFTER POWERING ON. NO SEGMENTS ARE MISSING FROM THE RESULTS FIELD BUT THE RESULTS FIELD IS DIFFICULT TO READ DUE TO THE SCREEN BEING DIM. NO MISINTERPRETATION OF RESULTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969561 ↗
• MalfunctionDec 6, 2022No Device Output; No Device Output

  THE CUSTOMER REPORTED AN EXPIRATION DATE ISSUE WITH COAGUCHEK VANTUS METER SERIAL NUMBER (B)(4). THE CUSTOMER STATED THEY WERE ABLE TO USE TEST STRIP LOT 52333121 THAT HAS AN EXPIRATION DATE OF 31-JUL-2022. THE METER SHOULD DISPLAY THE ERROR MESSAGE M-22 WHEN A CUSTOMER ATTEMPTS TO USE EXPIRED TEST STRIPS. THE CUSTOMER STATED THEY HAD A LOW RESULT OF 1.9 INR USING THE EXPIRED TEST STRIPS. THEIR DOSE WAS INCREASED BY A HALF TABLET FOR ONE DAY BASED ON THE RESULTS. CUSTOMER HAD NO HARM FROM DOSING BASED OFF THE METER READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927341 ↗
• MalfunctionNov 28, 2022Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK VANTUS METER. WHEN THE PATIENT TURNED THE METER ON TO RUN A TEST, 3 ONE-INCH-LONG BLACK VERTICAL "BLOBS" WERE ACROSS THE DISPLAY SCREEN. THE LINES WERE FROZEN ON THE DISPLAY SCREEN AND THE METER WOULD NOT PROCEED TO RUN A TEST. NO TESTS COULD BE RUN ON THE METER. WHEN THE PATIENT TESTED ON THE METER APPROXIMATELY 2 MONTHS AGO THE DISPLAY SCREEN WAS "FINE" AND THE RESULTS COULD BE READ CLEARLY. THERE WERE NO MISSING SEGMENTS ON THE DISPLAY SCREEN AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869382 ↗
• InjuryOct 29, 2022No Device Output; Device Difficult to Setup or Prepare; No Device Output; Device Difficult to Setup or Prepare

  THERE WAS AN ALLEGATION THE PATIENT WAS UNABLE TO TEST ON THE COAGUCHEK VANTUS METER DUE TO ERROR MESSAGES AND WAS CONSEQUENTLY PRESCRIBED LOVENOX INJECTIONS TO TREAT A LOW INR RESULT. ON (B)(6) 2022 THE PATIENT REPORTEDLY OBTAINED A SUCCESSFUL RESULT OF 2.3 INR ON THE METER. THE PATIENT¿S THERAPEUTIC RANGE IS REPORTEDLY 2 ¿ 3 INR WITH AN ALLEGED TESTING FREQUENCY OF WEEKLY. FOLLOWING THAT RESULT, THE PATIENT ALLEGED HE WAS UNABLE TO TEST ON THE METER DUE TO M-44 AND M-41 ERROR MESSAGES. ON (B)(6) 2022 THE PATIENT¿S WARFARIN DOSE WAS REPORTEDLY DECREASED BASED ON THE RESULT OF 2.3 INR. ON (B)(6) 2022 THE PATIENT ATTEMPTED TO TEST AND ALLEGEDLY RECEIVED M-41 AND M-44 ERROR MESSAGES. ON (B)(6) 2022 THE PATIENT ATTEMPTED TO TEST AND ALLEGEDLY RECEIVED M-41 AND M-44 ERROR MESSAGES. ON (B)(6) 2022 THE PATIENT WENT TO THE PHYSICIAN¿S OFFICE FOR TESTING AND THE LAB RESULT FROM AN UNKNOWN METHOD WAS REPORTEDLY 1.6 INR. THE PATIENT WAS ALLEGEDLY PRESCRIBED LOVENOX INJECTIONS TO TREAT THE LOW INR RESULT. NO OTHER TREATMENT WAS RECEIVED AND THE PATIENT WAS NOT HARMED BY THE LOVENOX INJECTIONS. THE PATIENT¿S CURRENT CONDITION IS REPORTEDLY "NORMAL." THE PATIENT WAS REPORTEDLY USING STRIP LOT 6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694420 ↗
• MalfunctionOct 12, 2022Display or Visual Feedback Problem; Non Reproducible Results; Display or Visual Feedback Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A DISPLAY PROBLEM ON A COAGUCHEK VANTUS METER. IT WAS REPORTED THAT THE METER HAD TO BE SHAKEN TO OBTAIN A RESULT. THE CUSTOMER STATED THAT THE METER FIRST DISPLAYED AN M-42 ERROR. PER PRODUCT LABELING, THIS ERROR INDICATES "NOT ENOUGH SAMPLE WAS APPLIED. REPEAT TEST WITH A NEW TEST STRIP." THE METER WAS SHAKEN WITH THE SAME TEST STRIP IN THE METER AND THEN A RESULT OF 1.7 INR WAS DISPLAYED. THE METER MEMORY WAS CHECKED WHICH SHOWED THE RESULT OF 1.7 INR. A DISPLAY TEST WAS PERFORMED SUCCESSFULLY. THE STRIP LOT IS 58944025 AND THE EXPIRATION DATE IS 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591172 ↗
• MalfunctionAug 29, 2022Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE DISPLAY OF COAGUCHEK VANTUS METER SERIAL NUMBER (B)(4). THE METER DISPLAY WAS ENTIRELY BLACK, BUT A TEST COULD STILL BE PERFORMED AND THE RESULT COULD BE TRANSMITTED WIRELESSLY. THE BATTERIES WERE REPLACED, BUT THE METER DISPLAY REMAINED ENTIRELY BLACK. A DISPLAY TEST COULD NOT BE PERFORMED. THE METER WAS NOT DROPPED OR EXPOSED TO LIQUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312638 ↗
• MalfunctionAug 12, 2022Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK VANTUS METER. THE CUSTOMER STATED THAT HE METER SOUNDS LIKE IT TURNS ON, BUT CANNOT SEE ANYTHING ON THE DISPLAY. CUSTOMER IS UNABLE TO SEE THE MENU OR ANYTHING ON THE SCREEN BECAUSE IT IS BLACK. CUSTOMER CHANGED BATTERIES THREE TIMES DUE TO THE ISSUE, BUT ISSUE PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218201 ↗
• MalfunctionAug 8, 2022Display Difficult to Read; Image Display Error/Artifact; Display Difficult to Read; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK VANTUS METER. THE CUSTOMER STATED THERE WERE BLACK LINES THROUGHOUT "MOST PARTS" OF THE DISPLAY SCREEN AND THERE WAS A BLACK CIRCLE IN THE LOWER RIGHT CORNER. A DISPLAY CHECK WAS PERFORMED AND THE SAME OBSERVATION WAS MADE. THE LAST RESULTS WERE CHECKED AND THE CUSTOMER COULD NOT MAKE OUT THE RESULT DUE TO THE DISPLAY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188184 ↗
• MalfunctionAug 5, 2022Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH A COAGUCHEK VANTUS METER. THE METER WENT DARK, AND THE PATIENT COULD NOT SEE THE SCREEN PROPERLY. ON (B)(6) 2022 THE CUSTOMER WAS ABLE TO COMPLETE THE TEST AND SEE THE RESULT OF 2.7 INR WITHOUT ISSUE. THE CUSTOMER DID NOT QUESTION THIS RESULT. THE CUSTOMER STATES THAT SHE WAS UNABLE TO ACCESS THE OPTIONS TO TRANSFER THE RESULT BECAUSE THE METER SCREEN WENT DARK. SHE TURNED THE METER ON AND SHE COULD SEE IT LIGHT UP, BUT WAS UNABLE TO SEE THE MENU OPTIONS. SHE TURNED THE METER ON AGAIN AND WAS UNABLE TO SEE DISPLAY BECAUSE IT WAS DARKER THAN BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179635 ↗
• MalfunctionJun 16, 2022Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS ALLEGED THAT A COAGUCHEK INRANGE METER (SERIAL NUMBER UNKNOWN) DISPLAYED A RESULT FOR A TEST STRIP THAT WAS NOT DOSED WITH A PATIENT'S SAMPLE. THE PATIENT DID NOT APPLY SAMPLE TO THE TEST STRIP, BUT THE METER DISPLAYED A RESULT IN THE "2.0S", LIKE A 2.4 INR OR A 2.7 INR. THE SPECIFIC VALUE WAS NOT KNOWN. THE DISPLAY APPEARED TO BE COMPLETE ACCORDING TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712005 ↗
• InjuryJun 9, 2022Circuit Failure; Adverse Event Without Identified Device or Use Problem; Circuit Failure; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN ALLEGATION OF COAGUCHEK VANTUS METER ERROR MESSAGES THAT PROHIBITED THE PATIENT FROM BEING ABLE TO PERFORM INR TESTS. REPORTEDLY THE PATIENT HAD A CLOT IN HER NECK AND IS IN THE HOSPITAL. THE REPORTER ALLEGED THEY HAD A MEASUREMENT OF 3.8 INR ON (B)(6) 2022. THE RETURNED METER MEMORY CONFIRMED A MEASUREMENT OF 3.8 INR ON (B)(6) 2022 AT 04:25 A.M.. THE PATIENT'S WARFARIN DOSAGE WAS DECREASED BY 1 MG. THE TEST STRIP LOT NUMBER WAS 56561321 WITH AN EXPIRATION DATE OF 31-MAY-2023. AFTER THE READING OF 3.8 INR, ADDITIONAL ATTEMPTS WERE ALLEGEDLY MADE TO TEST ON (B)(6) 2022 AND IT WAS REPORTED THE COAGUCHEK VANTUS METER SHOWED AN M-31 MESSAGE. THE REPORTER CONFIRMED THE BATTERY COMPARTMENT WAS CLEAN AND DRY. FOR MESSAGE M-31, PRODUCT LABELING STATES, "BATTERIES EMPTY: BATTERIES ARE NEARLY EMPTY. REPLACE BATTERIES NOW." REPORTEDLY THE METER'S BATTERIES WERE REPLACED AND THE BATTERY CONTACTS WERE CLEANED, BUT THE ISSUE PERSISTED. THE REPORTER STATED THE METER'S BATTERIES WERE REPLACED AGAIN BUT THE METER DISPLAYED AN ERROR MESSAGE E-63. FOR E-63, PRODUCT LABELING STATES, "METER ERROR: HARDWARE OR ELECTRONIC ERROR. POWER METER OFF AND ON. IF ERROR PERSISTS, CONTACT ROCHE DIAGNO

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14648686 ↗
• MalfunctionApr 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Device Handling Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Handling Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH A COAGUCHEK VANTUS METER. THE METER SHOWED A DUPLICATE RESULT IN THE METER MEMORY. THE PATIENT ONLY TESTED ONE TIME ON (B)(6) 2022. THE METER MEMORY SHOWED THE FOLLOWING RESULTS. ON (B)(6) 2022 THE METER RESULT WAS 4.3 INR AT 15:57. ON (B)(6) 2022 THE METER RESULT WAS 4.3 INR AT 16:03. THE RESULT WAS REPORTED AND THE PATIENT WAS ADVISED TO HOLD WARFARIN FOR 2 DAYS. THERE WERE NO NEGATIVE EFFECTS FROM HOLDING MEDICATION. THE PATIENT'S THERAPEUTIC RANGE IS 2.5-3.5 INR. THE TEST STRIP LOT NUMBER IS 49682521 WITH AN EXPIRATION DATE OF 30-APR-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119330 ↗
• MalfunctionFeb 17, 2022Failure to Transmit Record; Patient Data Problem; Failure to Transmit Record; Patient Data Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH A COAGUCHEK VANTUS METER. THE METER SHOWED RESULTS IN THE METER MEMORY THAT THE PATIENT DID NOT REMEMBER RECEIVING. THE METER MEMORY SHOWED THE FOLLOWING RESULTS: ON (B)(6) 2022 THE RESULT AT 9:27 A.M. WAS 2.5 INR. THE PATIENT REMEMBERS RECEIVING THIS RESULT. ON (B)(6) 2022 THE RESULT AT 12:54 P.M. WAS 3.9 INR. ON (B)(6) 2022 THE RESULT AT 9:14 P.M. WAS 4.2 INR. ON (B)(6) 2022 THE RESULT AT 1:18 P.M. WAS 4.8 INR. ON (B)(6) 2022 THE RESULT AT 10:17 A.M. WAS > 6.0 INR. ON (B)(6) 2022 THE RESULT AT 10:25 A.M. WAS > 6.0 INR. THE PATIENT DID NOT REMEMBER RECEIVING ANY OF THE RESULTS LISTED BETWEEN (B)(6) 2022. ALL OF THE RESULTS BETWEEN (B)(6) 2022 WERE SENT TO THE PATIENT¿S DOCTOR AT ONCE VIA THE REMOTE INR MOBILE APP. THE PATIENT'S THERAPEUTIC RANGE IS 2.5 - 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549880 ↗
• MalfunctionDec 13, 2021Circuit Failure; Circuit Failure

  THERE WAS A COMPLAINT OF A MELTED BATTERY IN A COAGUCHEK VANTUS METER. THE CUSTOMER PUT IN NEW BATTERIES DUE TO RECEIVING A LOW BATTERY ERROR. AFTER REPLACING THE BATTERIES BEFORE PUTTING THE COVER BACK ON, THE CUSTOMER NOTICED THE METER GOT WARM AND STATED ONE OF THE BATTERIES HAD MELTED. THERE WAS NO SMOKE OR FIRE AND THE CUSTOMER DID NOT SUFFER ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983495 ↗
• MalfunctionAug 11, 2021Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER COMPLAINED OF A DISPLAY ISSUE WITH COAGUCHEK VANTUS METER SERIAL NUMBER (B)(4). THE METER HAS A GRAY BAR DOWN THE CENTER OF THE DISPLAY. HALF THE SCREEN IS WHITE AND THE OTHER HALF IS DIFFICULT TO READ. 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 12306057 ↗
• MalfunctionJul 14, 2021Display Difficult to Read; Display Difficult to Read

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK VANTUS METER. WHEN RUNNING A TEST, THE RESULT APPEARS BUT THE CUSTOMER HAD DIFFICULTY READING THE INR ON THE DISPLAY. THE RESULT APPEARS AS "WHITE ON WHITE". A DISPLAY TEST WAS PERFORMED AND IT WAS CONFIRMED THAT ALL FOUR COLORED SCREENS WERE CLEARLY VISIBLE. THERE WAS NO ACTUAL MISINTERPRETATION OF ANY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168268 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170960. One submission often covers many models, so check the product and lot details in each record.

• Z-0360-2019 · Sep 13, 2018 · Terminated
  CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS P