CoaguChek XS PT strips 7797826160Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04015630946471), received between Aug 9, 2018 and Jun 23, 2025 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “High Test Results” (20 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. 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Component Missing; Component Missing

  WE RECEIVED AN ALLEGATION THAT THE COAGUCHEK XS PT TEST 1X24 STRIPS BOX AND BOTTLE EXPIRATION DATES, AND THE TEST STRIP BOX AND THE CODE ON THE TEST STRIP DO NOT MATCH. THE REPORTER STATED THAT THE BOX'S EXPIRATION DATE IS 31-JUL-2025, AND THE BOTTLE'S IS 30-APR-2025; THE TEST STRIP CODE ON THE BOX IS 138, AND THE CODE ON THE TEST STRIP IS 117. THE REPORTER DID NOT USE THE TEST STRIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307149 ↗
• MalfunctionAug 7, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS WITH COAGUCHEK XS PLUS METER (SERIAL NUMBER (B)(6)) COMPARED TO AN UNKNOWN LABORATORY METHOD. AT 8:00 A.M. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 3.9 INR. BETWEEN 8:00 AND 9:00 A.M. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING AN UNKNOWN LABORATORY METHOD, RESULTING IN A VALUE OF 2.63 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR, WITH A TESTING FREQUENCY OF EVERY 6 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468850 ↗
• MalfunctionAug 7, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER (SERIAL NUMBER (B)(6) COMPARED TO AN UNKNOWN LABORATORY METHOD. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF > 8.0 INR, ACCOMPANIED BY A DATA FLAG. A REPEAT TEST WAS PERFORMED ON THE METER BY USING A SAMPLE FROM THE SAME FINGER OF THE PATIENT AND THE RESULT WAS 7.8 INR. AT THE SAME TIME, A SAMPLE FROM THE PATIENT WAS TESTED USING AN UNKNOWN LABORATORY METHOD, RESULTING IN A VALUE OF 5.3 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468633 ↗
• MalfunctionJul 20, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS WITH A COAGUCHEK XS METER COMPARED TO AN UNKNOWN LABORATORY METHOD. THE RESULT FROM THE METER AT 10:30 A.M. WAS 1.6 INR. THE RESULT FROM THE LABORATORY FROM A SAMPLE DRAWN AT THE SAME TIME WAS 2.7 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR WITH A TESTING FREQUENCY OF WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366747 ↗
• MalfunctionJul 17, 2023High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6) COMPARED TO A LABORATORY USING AN UNKNOWN REAGENT. THE PATIENT TESTED ON THEIR PERSONAL COAGUCHEK XS METER SERIAL NUMBER (B)(6) AND THE RESULT WAS 6.8 INR. THE PATIENT THEN TESTED ON THE PROFESSIONAL METER AND THE RESULT WAS 6.6 INR. THE RESULT FROM THE LABORATORY WITHIN FOUR HOURS WAS 4.9 INR. PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE PATIENT TESTS ON A WEEKLY BASIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339570 ↗
• MalfunctionMay 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER UP(B)(6). AT 5:50 PM, THE METER RESULT WAS 5.3 INR. AT 5:58 PM, THE METER RESULT WAS 4.5 INR. AT 6:00 PM, THE METER RESULT WAS 6.0 INR. CUSTOMER'S THERAPEUTIC RANGE IS 2.5-3.5 INR. THE CUSTOMER TESTS EVERY WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955697 ↗
• MalfunctionMay 2, 2023High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6) COMPARED TO A LABORATORY USING AN UNKNOWN REAGENT. AT 2:15 PM, THE METER RESULT WAS 3.7 INR. THE TEST WAS REPEATED ON THE METER WITHIN FOUR HOURS AND THE RESULT WAS 2.9 INR. THE RESULT FROM THE LABORATORY WITHIN FOUR HOURS OF THE METER TESTS WAS 2.3 INR. PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE PATIENT IS TESTED ON A WEEKLY OR BIWEEKLY BASIS DEPENDENT UPON THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855046 ↗
• MalfunctionFeb 2, 2023High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A LABORATORY USING AN UNKNOWN REAGENT. AT 9:30 AM, THE METER RESULT WAS 4.3 INR. AT 12:30 PM, THE RESULT FROM THE LABORATORY WAS 3.0 INR. PATIENT'S THERAPEUTIC RANGE IS 2.5-3.5 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284921 ↗
• MalfunctionJan 11, 2023Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR 1 PATIENT TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). ON (B)(6) 2022 THE PATIENT HAD AN INITIAL METER RESULT OF 3.5 INR WHILE UPON RE-TEST THE METER RESULT WAS 4.6 INR. THE TIME DIFFERENCE BETWEEN THE TESTS WAS WITHIN 4 HOURS. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE PATIENT'S INTERVAL OF TESTING IS DAILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141509 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  IT WAS REPORTED THAT A PATIENT RECEIVED A DISCREPANT RESULT WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 18:31, THE PATIENT HAD A METER RESULT OF 4.9 INR. THE PATIENT THEN WENT TO THE EMERGENCY ROOM. AT AROUND 8 P.M., A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY AT THE EMERGENCY ROOM USING AN UNKNOWN METHOD, RESULTING IN A VALUE OF 3.3 INR. THE PATIENT'S THERAPEUTIC RANGE IS 1.5 - 2.5 INR. THE PATIENT'S TESTING INTERVAL IS EVERY 2 - 3 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563104 ↗
• MalfunctionSep 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF ERROR MESSAGES, AN INCORRECT DATE, AND LOW RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE CUSTOMER COULD NOT REMEMBER SPECIFIC DATE OF THE EVENT OTHER THAN "IT WAS A LONG TIME AGO". THE CUSTOMER COULD NOT REMEMBER SPECIFIC RESULTS. HE ALLEGED THE RESULT FROM THE METER WAS LOW (BELOW 2.0 INR) AND A REPEAT TEST WAS INSIDE HIS THERAPEUTIC RANGE OF 2.5-3.5 INR. THE CUSTOMER TESTS ONCE A MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496536 ↗
• MalfunctionSep 8, 2022High Test Results; High Test Results

  K.N 12/22/2022 THE REPORTER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. THE RESULT FROM THE METER WAS 2.3 INR. THE RESULT FROM THE LABORATORY WAS 1.8 INR. ON (B)(6) 2022 AT APPROXIMATELY 5:04 PM, THE METER RESULT WAS 2.6 INR. THE RESULT FROM THE LABORATORY WAS 2.0 INR. ON (B)(6) 2022 AT 4:15 PM, THE RESULT FROM THE METER WAS 3.1 INR. THE RESULT FROM THE LABORATORY AT THE SAME TIME WAS 2.3 INR. THE PATIENT'S THERAPEUTIC RANGE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382266 ↗
• MalfunctionAug 25, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 9 AM, THE RESULT FROM THE METER WAS >8.0 INR. AT 10:30 AM, THE RESULT FROM A LABORATORY USING AN UNKNOWN REAGENT WAS 6.0 INR. THE PATIENT WAS TO SKIP THE WARFARIN DOSE FOR THIS DATE AND TAKE HALF OF THE DOSE THE NEXT DAY. THE THERAPEUTIC RANGE WAS 3.0-4.0 INR AND TESTS EVERY THREE WEEKS. THE PATIENT HAD A PARASITE THAT CAUSED ISSUES WITH THEIR STOMACH AND HAD NOT BEEN EATING AS MUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294607 ↗
• MalfunctionJul 22, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A LABORATORY USING AN UNKNOWN LAB REAGENT. AT 8:34 AM, THE METER RESULT WAS 6.8 INR. AT 9:34 AM, THE RESULT FROM THE LABORATORY WAS 4.4 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.5-3.5 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089301 ↗
• MalfunctionMay 31, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS FOR 1 PATIENT TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. THE METER RESULT WAS 3.4 INR. THE LABORATORY RESULT WAS 2.0 INR. THE SAMPLES FOR EACH TEST WERE OBTAINED AT THE SAME TIME. THE PATIENT¿S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546158 ↗
• MalfunctionMay 11, 2022High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED ON A COAGUCHEK XS METER SERIAL NUMBER UP1071193 COMPARED TO AN UNKNOWN LABORATORY METHODOLOGY. ON (B)(6) 2022 AND AT 1:35 P.M., THE PATIENT'S METER RESULT WAS 7.2 INR. AT 2:13 P.M., THE PATIENT'S LABORATORY RESULT WAS 4.7 INR. ON (B)(6) 2022 AND AT 9:56 A.M., THE PATIENT'S METER RESULT WAS 5.8 INR. AT 12:20 P.M., THE PATIENT'S LABORATORY RESULT WAS 4.4 INR. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE PATIENT'S TESTING FREQUENCY IS EVERY TWO WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14351052 ↗
• MalfunctionMay 10, 2022High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED ON A COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHODOLOGY. FOR EACH METER TEST, IT WAS REPORTED THE PATIENT USED A NEW FINGER FOR SAMPLE COLLECTION. ON (B)(6) 2022 AND "AROUND" 10:00 A.M., THE PATIENT¿S METER RESULT WAS 6.1 INR. ON (B)(6) 2022 AND "AROUND" 10:00 A.M., THE PATIENT¿S METER RESULT WAS 5.9 INR WITH A DIFFERENT FINGER. ON (B)(6) 2022 AND AT 1:30 P.M., THE PATIENT¿S LABORATORY RESULT WAS 3.6 INR. ON (B)(6) 2022 AND AT 13:12, THE PATIENT¿S METER RESULT WAS >8.0 INR. ON (B)(6) 2022 AND AT 13:15, THE PATIENT¿S METER RESULT WAS 8.0 INR WITH A DIFFERENT FINGER. ON (B)(6) 2022 AND AT 16:46, THE PATIENT¿S LABORATORY RESULT WAS 4.7 INR. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE PATIENT'S TESTING FREQUENCY IS EVERY TWO WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347446 ↗
• MalfunctionMar 21, 2022Improper or Incorrect Procedure or Method; High Test Results; Improper or Incorrect Procedure or Method; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED WITH A COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHODOLOGY. FOR METER TESTING, THE NURSE WIPED AWAY THE PATIENT'S FIRST DROP OF BLOOD AND USED THE SECOND DROP FOR SAMPLE COLLECTION. ALSO, A DIFFERENT FINGER WAS USED FOR EACH METER RESULT THE PATIENT'S METER RESULTS WERE ">8.0" INR AND ">8.0" INR. THE PATIENT'S LABORATORY RESULT WAS 5.8 INR. ALL TESTS WERE COMPLETED WITHIN 30 MINUTES. THE PATIENT'S DOSE WAS WITHHELD BASED ON THE LABORATORY RESULT. THE PATIENT'S THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE PATIENT'S TESTING FREQUENCY IS WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841340 ↗
• MalfunctionMar 14, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. AT 11:45 AM, THE METER RESULT WAS 4.3 INR. AT 12:05 PM, THE RESULT FROM THE LABORATORY WAS 2.9 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759838 ↗
• MalfunctionFeb 16, 2022High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED WITH THE COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. THE METER RESULT WAS 5.1 INR. AFTER A FEW MINUTES, THE LABORATORY RESULT WAS 3.9 INR. THE THERAPEUTIC RANGE IS 2.0 TO 3.0 INR AND TESTING IS PERFORMED WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542767 ↗
• MalfunctionDec 28, 2021High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED ON TWO COAGUCHEK XS METERS COMPARED TO AN UNKNOWN LABORATORY METHODOLOGY. ON (B)(6) 2021 AND AT 10:26, THE PATIENT'S INR RESULT WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) AND TEST STRIP LOT 53224317 WAS 8.0 INR. WITHIN FOUR HOURS, THE PATIENT'S LABORATORY RESULT WAS 4.8 INR. THE PATIENT WITHHELD COUMADIN BASED ON THE 4.8 INR RESULT. ON (B)(6) 2021, THE PATIENT'S INR RESULT WITH AN UNKNOWN COAGUCHEK METER AND AN UNKNOWN TEST STRIP LOT WAS 8.0 INR. WITHIN FOUR HOURS, THE PATIENT'S LABORATORY RESULT WAS 5.2 INR. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE PATIENT'S TESTING FREQUENCY WAS REPORTED "AS NEEDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094736 ↗
• MalfunctionOct 21, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT TESTED WITH THE OFFICE'S COAGUCHEK XS PROFESSIONAL METER SERIAL NUMBER (B)(4). THE RESULTS MEASURED WITH THE OFFICE METER DID NOT MATCH RESULTS OBTAINED WITH THE PATIENT'S COAGUCHEK XS METER (SERIAL NUMBER (B)(4)) AND RESULTS OBTAINED WITH LABORATORY TESTING. AT 1:20 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING OFFICE METER SERIAL NUMBER (B)(4) , RESULTING IN A VALUE OF 3.3 INR. AT 1:35 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING OFFICE METER SERIAL NUMBER (B)(4), RESULTING IN A VALUE OF 3.5 INR. AT THE SAME TIME OF THE FIRST TWO MEASUREMENTS, A SAMPLE FROM THE PATIENT WAS TESTED USING THE PATIENT'S COAGUCHEK XS METER AND TEST STRIP LOT 52818122 (EXPIRATION DATE UNKNOWN), RESULTING IN A VALUE OF 6.9 INR. THE REPORTER DID NOT OBSERVE THE PATIENT WHILE THE METER MEASUREMENTS WERE PERFORMED, SO THE REPORTER DID NOT KNOW IF DIFFERENT FINGERS OF THE PATIENT WERE USED FOR EACH SAMPLE COLLECTED FOR EACH OF THE METER MEASUREMENTS. THE REPORTER EXPLAINED THAT THE TEST STRIP VIAL USED FOR TESTING ON THE OFFICE METER WAS A MIX OF THE TEST STRIPS USED ON THE OFFICE METER AND ANOTHER VIAL THEY HAD AT THE OFFIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674866 ↗
• InjurySep 7, 2021High Test Results; High Test Results

  THE INITIAL REPORTER, A NURSE TREATING THE PATIENT, ALLEGED THAT INCORRECT METER READINGS FROM THE COAGUCHEK XS METER SERIAL NUMBER (B)(4) LED TO A PATIENT HAVING A SMALL DEEP VEIN THROMBOSIS (DVT) IN HIS LEG. THE NURSE ALLEGED METER READINGS GAVE HIGHER RESULTS WHEN COMPARED TO THE LABORATORY. THE NURSE DID NOT PERFORM THE TESTING OR OBSERVE THE METER READINGS AND COULD NOT PROVIDE ANY DATES/TIMES BUT ESTIMATED THE METER RESULTS WERE AROUND 6.0 INR AND THE LABORATORY RESULTS WERE AROUND 1.2 INR AND ALL TESTING WAS PERFORMED AT THE SAME TIME. UPON GATHERING FURTHER INFORMATION, THE NURSE ADVISED THE PATIENT¿S METER RESULTS WERE 4.0 INR OR HIGHER AND THE LABORATORY RESULTS WERE AROUND 1.6 INR ON THE SAME DAY AT THE SAME TIME. THE NURSE ADVISED THE PATIENT¿S WARFARIN DOSE WAS BASED ON THE METER RESULTS, BECAUSE IT TOOK SEVERAL DAYS TO OBTAIN THE LAB RESULT. THE NURSE ADVISED THE PATIENT COMPLAINED OF LOWER LEG PAIN AND SWELLING. WHEN REDNESS WAS NOTICED THEY SENT HIM TO HIS DOCTOR AND A SMALL DVT IN HIS LOWER LEG WAS CONFIRMED. THE NURSE STATED SHE BELIEVES THE PATIENT'S NORMAL WARFARIN DOSE WAS 5MG FOR 3 DAYS AND EITHER 2.5 OR 2.0 MG THE REST OF THE DAYS BUT IS NOT CERTAIN. THE NURS

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 12436340 ↗
• MalfunctionJul 27, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE INR RESULTS WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. THE RESULT FROM THE METER AT 12:40 P.M. WAS >8.0 INR. THE REPORTER STATED SHE HAD TO EXCESSIVELY SQUEEZE TO GET A DROP FROM THE FINGER. THE REPORTER DID A VENOUS DRAW ON THE PATIENT AT 12:54 P.M. WITH A METER RESULT OF >8.0 INR. THE RESULT FROM THE LABORATORY WITHIN 4 HOURS WAS 2.67 INR. THE PATIENT¿S THERAPEUTIC RANGE IS AROUND 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233614 ↗
• MalfunctionSep 25, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS FOR 2 PATIENTS FROM COAGUCHEK PLUS METER SERIAL NUMBER (B)(4). FOR PATIENT 1 THE RESULTS FROM THE METER WERE 7.2 INR, 4.8 INR, AND 4.2 INR WITH THE SAME FINGER. FOR PATIENT 2 THE RESULTS FROM THE METER WERE 3.4 INR, 2.6 INR, AND 3.3 INR WITH THE SAME FINGER. PATIENT 2 WAS A (B)(6) FEMALE WITH A DATE OF BIRTH OF (B)(6). THE SPECIFIC TIME OF THE MEASUREMENTS WAS NOT PROVIDED. THE ELAPSED TIME BETWEEN THE MEASUREMENTS WAS WITHIN 15 MINUTES FOR BOTH PATIENTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENTS' WARFARIN DOSES WERE ADJUSTED BASED ON THE RESULTS FROM THE METER. THE PATIENTS WERE FEELING "OKAY". THE PATIENTS WERE NOT ANEMIC, NO HEPARIN, NO ANTIPHOSPHOLIPID ANTIBODIES, AND NO DIRECT THROMBIN INHIBITORS. THE PATIENTS HAD NO CHANGES IN DIET, NO NEW ILLNESS, NO NEW MEDICATIONS, NO BLEEDING, AND NO BRUISING. THE PATIENTS' THERAPEUTIC RANGES WERE 2.0 - 3.0 INR. RETENTION TEST STRIPS (LOT 294947) WERE TESTED IN COMPARISON TO MASTER LOT. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL COMPLIES WITH THE SPECIFICATION. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905453 ↗