i-STAT 03P89-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10054749000170), received between Mar 24, 2017 and Feb 13, 2024 — classified as 127 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (123 reports).

5 other recalls cover devices cleared under the same FDA submission (K020355); 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 02-FEB-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT INR RESULTS A 63 YEAR OLD FEMALE PATIENT WITH DEEP VEIN THROMBOSIS. THERE WAS NO ADDITIONAL NFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS (SEC) SAMPLE I-STAT (B)(6) 2024 11:46 11:50 *>8 5 ACL TOP (B)(6) 2024 12:50 13:50 4.1 6 AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY. PT/INR - INTENDED USE THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696283 ↗
• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 09-JAN-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT INR RESULTS A 47 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL NFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, COLLECTED , TESTED , INR, SAMPLE TYPE. I-STAT, (B)(6) 2023 , 09:29, 09:29 , 4.6 , CAPILLARY. I-STAT , (B)(6) 2023, 09:58 , 09:58, 5.8, CAPILLARY. ACL TOP, (B)(6) 2023 , 10:07, 10:41, 3.9, SODIUM CITRATE. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY. PT/INR - INTENDED USE. THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521506 ↗
• MalfunctionNov 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091754 ↗
• MalfunctionNov 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 31-OCT-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT INR RESULTS A 69 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED PT INR SAMPLE I-STAT, 31-OCT-2023, 08:58, 09:00 NI, >6.0 INR FINGER STICK. STAGO, 31-OCT-2023, 09:23, 09:25, 38.8 3.8 INR, VENOUS/WB. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY. PT/INR - INTENDED USE. THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091750 ↗
• MalfunctionJun 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT INR RESULTS A 53 YEAR OLD FEMALE PATIENT SEEN FOR A MECHANICAL VALVE REPLACEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED INR SAMPLE I-STAT (B)(6) 2023 02:23 02:23 4.0 WHOLE BLOOD- A. STAGO (B)(6) 2023 02:02 NI 2.6 PLASMA- B. PT/INR, INTENDED USE THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Valvular Stenosis

  MAUDE report 17126519 ↗
• MalfunctionJun 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT INR RESULTS A 78 YEAR OLD FEMALE PATIENT WITH A HISTORY OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED INR SAMPLE I-STAT: (B)(6) 2023, 02:52, 02:52, 3.7, WHOLE BLOOD- A. STAGO: (B)(6) 2023, 03:32, NI, 2.5, PLASMA- B. PT/INR - INTENDED USE, THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 17126518 ↗
• MalfunctionJun 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 31-MAY-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT INR RESULTS A 31 YEAR OLD FEMALE PATIENT WITH CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH). THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. TREATMENT WAS BASED ON THE LAB, NOT ON I-STAT RESULTS. THE CUSTOMER STATES THAT WARFARIN WAS HELD UNTIL VENOUS BLOOD DRAW RESULTED. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DRAW DATE COLLECTED INR SAMPLE ID I-STAT , FINGERSTICK, (B)(6) 2023 , 13:34 , 7.8, (B)(6). I-STAT, FINGERSTICK, (B)(6) 2023, 13:50 , 4.6, (B)(6). LAB, VENOUS , (B)(6) 2023, 15:33 , 3.3, (B)(6). PT/INR - INTENDED USE THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Pulmonary Hypertension

  MAUDE report 17060150 ↗
• MalfunctionJan 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 19-JAN-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT INR RESULT OF 2.9 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD : I-STAT, DATE: 18-JAN-2023, RESULT (UNITS): 2.9; METHOD : LAB, DATE: 18-JAN-2023, RESULT (UNITS): 0.99. PT/INR - INTENDED USE: THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN. THE CUSTOMER REPORTS THAT THE PATIENT IS NOT ON ORAL ANTICOAGULANT (COUMADIN OR WARFARIN) THERAPY. AS PER PROTHROMBIN TIME, PT/INR IFU ART: 715236-00S. THE CUSTOMER WAS ADVISED OF OFF LABEL USE AND THE INTENDED USE FOR THE I-STAT PT/INR. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232912 ↗
• MalfunctionJan 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT INR RESULT OF 4.2 ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD, DATE, RESULT (UNITS). I-STAT, (B)(6) 2023, 4.2. LAB, (B)(6) 2023, 0.9. PT/INR - INTENDED USE: THE I-STAT PT, A PROTHROMBIN TIME TEST, IS USEFUL FOR MONITORING PATIENTS RECEIVING ORAL ANTICOAGULATION THERAPY SUCH AS COUMADIN ® OR WARFARIN. THE CUSTOMER REPORTS THAT THE PATIENT IS NOT ON ORAL ANTICOAGULANT (COUMADIN OR WARFARIN) THERAPY. AS PER PROTHROMBIN TIME, PT/INR IFU ART: 715236-00S. THE CUSTOMER WAS ADVISED OF OFF LABEL USE AND THE INTENDED USE FOR THE I-STAT PT/INR. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232910 ↗
• MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 48 YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. I-STAT, (B)(6) 2022, 15:39 15:39 4.6 FINGERSTICK: STAGO. (B)(6) 2022, 15:10 16:00 2.73 VENOUS. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093727 ↗
• MalfunctionJan 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 62 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD, DATE COLLECTED, TESTED RESULT, SAMPLE: I-STAT, (B)(6) 2022, 14:20 14:20 >4.0, FINGERSTICK AND STAGO, (B)(6) 2022 18:10 20:29 2.93, VENOUS. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093725 ↗
• MalfunctionNov 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Vasculitis

  MAUDE report 15874285 ↗
• MalfunctionNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 75 YEAR OLD MALE PATIENT WITH AN ANTICOAGULATION EPISODE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: ACL TOP AND I-STAT. DATE:ON (B)(6). TIME: 16:29 AND NI RESULTS: 4.2 AND 2.6. SAMPLE: FINGERSTICK #2 AND VENOUS #2. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15753445 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 27-OCT-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 50 YEAR OLD MALE PATIENT WITH DEEP VEIN THROMBOSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT. DATE: (B)(6) 2022. RESULT: >4.5. METHOD: ACL TOP 750 . DATE: (B)(6) 2022. RESULT: 3.8. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15736190 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 27-OCT-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 28 YEAR OLD MALE PATIENT WITH DEEP VEIN THROMBOSIS. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT. DATE: (B)(6). RESULT: >4.5. METHOD: ACL TOP 750. DATE: (B)(6) 2022. RESULT: 3.9. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15735482 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 75 YEAR OLD MALE PATIENT WITH DEEP VEIN THROMBOSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE, AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE:(B)(6) 2022, RESULT: >4.5. METHOD: ACL TOP 750, DATE: (B)(6) 2022, RESULTS: 3.8. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15734962 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 27-OCT-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 56 YEAR OLD MALE PATIENT WITH LV MURAL THROMBOSIS. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT. DATE: (B)(6) 2022. RESULT: >4. METHOD: ACL TOP 750. DATE (B)(6) 2022. RESULT: 3.7. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15734418 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 27-OCT-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 61 YEAR OLD MALE PATIENT WITH DEEP VEIN THROMBOSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT. DATE: (B)(6) 2022. RESULT: >4.5. METHOD: ACL TOP 750. DATE: (B)(6) 2022. RESULT: 3.3. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15725779 ↗
• MalfunctionNov 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT ON A 94 YEAR OLD MALE PATIENT WITH ATRIAL FIBRILLATION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, RESULT . I-STAT, (B)(6) 2022, >4.5. ACL TOP 750, (B)(6) 2022, 2.8. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Atrial Fibrillation

  MAUDE report 15722142 ↗
• MalfunctionAug 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PT/INR RESULTS ON A 72 YEAR OLD FEMALE PATIENT WITH LEFT FOOT WOUND DEBRIDEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (METHOD, DATE, COLLECTED, TESTED, RESULT, SAMPLE) I-STAT, (B)(6) 2022 , 06:54, 06:55, INR 6.5, FINGER STICK. I-STAT, (B)(6) 2022, 07:05, 07:06, INR 6.1, FINGER STICK. SYSMEX CF5100, (B)(6) 2022, 08:00, 08:54, INR 4.47, VENOUS/BLUE TOP TUBE. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Wound Dehiscence

  MAUDE report 15146223 ↗
• MalfunctionApr 27, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PT/INR RESULTS OF 3.6 ON A 55 YEAR OLD FEMALE PATIENT WITH CHRONIC ATRIAL FIBRILLATION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, COLLECT TEST, INR; I-STAT, (B)(6) 2022, 08:42, 08:42, 3.6; SYSMEX, (B)(6) 2022, 09:07, 10:58, 5.28. INR TARGET: 2.5-3.5. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218291 ↗
• MalfunctionApr 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022 ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PT/INR RESULTS OF 8.0 ON A 53 YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; LAB. DATE: 22-MAR-2022 ; 22-MAR-2022 . PT/INR: 8.0; 4.7. SAMPLE : VENOUS; VENOUS. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013189 ↗
• MalfunctionMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PT/INR RESULTS OF 4.4 AND 4.1 ON A 65 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869257 ↗
• MalfunctionMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 15-MAR-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT OF 4.6 ON A 31 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD, DATE, TESTED, PT (SEC), INR, SAMPLE; I-STAT, (B)(6) 2022, 10:49, 51.0, 4.6, A; LAB, (B)(6) 2022, 11:57, 33.9, 2.8, B. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869211 ↗
• MalfunctionMar 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PT/INR RESULTS OF 5.8 AND 6.8 INR ON A 79 YEAR OLD FEMALE PATIENT DOING ROUTINE IN-HOME MONITORING ON INR. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. I-STAT (B)(6) 2022 5.7 A, I-STAT (B)(6) 2022 6.8 B, I-STAT (B)(6) 2022 1.8 C. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020355. One submission often covers many models, so check the product and lot details in each record.

• Z-2361-2015 · Jun 15, 2015 · Terminated
  i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test usefu
• Z-0451-2014 · Oct 28, 2013 · Terminated
  Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulati
• Z-2157-2012 · Mar 1, 2012 · Terminated
  I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Couma
• Z-1996-2010 · May 5, 2010 · Terminated
  i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
• Z-0364-2007 · Dec 12, 2006 · Terminated
  i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 Product of Cana