i-STAT 03P86-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10054749000149), received between Oct 9, 2017 and Aug 6, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 reports).

4 other recalls cover devices cleared under the same FDA submission (K992571); 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161133 ↗
• MalfunctionJan 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 18564874 ↗
• MalfunctionNov 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 06-NOV-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DESCREPANT RESULTS ON A 57 YEAR OLD MALE PATIENT SEEN FOR CORONARY BYPASS GRAFTING X2 USING LEFT MAMMARY AND LEFT ENDOSCOPIC. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE COLLECTED TESTED RESULT (SEC) 06-NOV-2023 08:44 08:44 139 BASELINE 06-NOV-2023 09:45 09:45 782 06-NOV-2023 10:05 10:05 741 06-NOV-2023 10:12 10:12 139 HEPARIN TIMES/DOSE, REVERSAL INFORMATION PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPOPRTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175786 ↗
• MalfunctionNov 20, 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 ACT CELITE CARTRIDGES THAT YIELDED DESCREPANT RESULTS ON A 69 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE COLLECTED TESTED RESULT (SEC) ON (B)(6) 2023 12:24 12:24 139 BASELINE ON (B)(6) 2023 13:52 13:52 666 ON (B)(6) 2023 14:26 14:06 654 ON (B)(6) 2023 14:35 14:35 537 ON (B)(6) 2023 15:04 15:04 620 HEPARIN TIMES/DOSE, REVERSAL INFORMATION PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPOPRTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDERG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175740 ↗
• MalfunctionOct 11, 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 ACT CELITE CARTRIDGES THAT YIELDED DESCREPANT RESULTS ON A 79 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TESTED RESULTS (SECS). 08:58 268. 09:23 338. 09:50 151. 11:27 205. 11:40 255. 11:56 *276. 12:13 326. 12:52 230. NO DATE, COLLECT TIMES, HEPARIN TIMES/DOSE PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPOPRTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: (B)(4), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDERGOING MEDICAL PROCEDURES SUCH AS CATHETERIZATION, CARDIAC SURGERY, SURGERY, ORGAN TRANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911853 ↗
• MalfunctionOct 3, 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 ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON A 61 YEAR OLD MALE PATIENT PRESENTED WITH SHORTNESS OF BREATH, FLUTTER/HEAVINESS IN CHEST, NO SHARP PAINS IN CHEST. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. ANALYZER: DATE: COLLECTED: TESTED RESULT (SEC): I-STAT. (B)(6) 2023. 16:15. 16:15. >1000. I-STAT. (B)(6) 2023. 16:15. 16:15. 621. HEPARIN TIMES/DOSE WERE NOT PROVIDED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPORTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: (B)(4)), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859638 ↗
• MalfunctionAug 23, 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 ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. THE CUSTOMER STATES THAT RESULTS DID NOT CORRESPOND WITH CLINICAL PICTURE AS DOSAGE OF HEPARIN ADMINISTERED TO PATIENT DID NOT INCREASE THE ACT RESULT. RESULT (SEC):.231. BASELINE, 261, 237, 249, HEPARIN DOSAGE: 11000, 3000, 3000. NOTE: THERE WERE NO COLLECTION/TEST TIMES PROVIDED, NOR WERE THERE TIMES PROVIDED FOR HEPARIN DOSES ADMINISTERED TO THE PATIENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPORTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL ((B)(4)), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603973 ↗
• MalfunctionMay 25, 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 ACT CELITE CARTRIDGES THAT YIELDED QUALITY CHECK CODE 44 ON A PATIENT DURING SURGERY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. THE CUSTOMER STATES THAT ON (B)(6) 2023, QUALITY CHECK CODE 44 (QCC 44) OCCURRED MULTIPLE TIMES ON A PATIENT DURING A PROCEDURE WITH MULTIPLE ANALYZERS. OTHER CASES RUNNING THE SAME DAY WITH DIFFERENT PATIENTS AND USING THE SAME CARTRIDGE LOT FUNCTIONED AS EXPECTED. PER DOCTOR, A HEPARIN BOLUS AND DRIP WERE STARTED, WITH SERIAL MONITORING OF ACTS TO KEEP ACT BETWEEN 350-400 SECONDS. QCC 44 OCCURRED AND UNABLE TO OBTAIN AN I-STAT ACT RESULT. A SECOND ANALYZER WAS USED, AND QCC 44 OCCURRED. THE CATHETER WAS MOVED FROM THE LEFT INTO THE RIGHT. THREE ANALYZERS AND 8 CARTRIDGES WERE USED BUT QCC 44 PERSISTED. AFTER SPEAKING WITH THE LAB AND ABBOTT IT WAS CONFIRMED THAT THE ANALYZERS WERE WORKING, AND THIS WAS LIKELY A HEMATOLOGIC PROCESS. WITH THE INABILITY TO GO BACK LEFT SIDED GIVEN SAFETY AND RISK OF CVA, THE DOCTOR AGAIN ATTEMPTED THE VOM. THEY WERE ABLE TO CANNULATE IT WITH A WIRE BUT NOT THE GUID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001713 ↗
• MalfunctionApr 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 ACT CELITE CARTRIDGES (LOTS R22331 AND R23009) THAT YIELDED DISCREPANT RESULTS ON A PATIENT RECEIVING OPEN HEART SURGERY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THE I-STAT 1 SYSTEM DID NOT GIVE RESULTS FOR ACT AND GAVE BACK-TO-BACK QUALITY CHECK CODES 6 TIMES WHILE PATIENT WAS ON THE OPERATING TABLE WITH HEART BYPASSED DURING SURGERY. NO ACT RESULTS WERE ABLE TO BE OBTAINED FROM THE I-STAT 1 SYSTEM LEADING TO A DELAY IN PROCEEDING WITH THE NEXT STEPS DURING SURGERY. ALTHOUGH QUALITY CHECK CODES ARE PART OF THE I-STAT SYSTEM, IT WAS DETERMINED THAT A SIGNIFICANT DELAY OCCURRED DURING THE EVENT. THE CUSTOMER STATES THAT THE FACILITY WAS ABLE TO USE AN ALTERNATIVE METHOD (HEMOCHRON) TO GET ACT RESULTS AND PROCEED WITH THE SURGERY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT. FACILITY REPORTS THE PATIENT IS IN GOOD CONDITION AFTER THE SURGERY. REFER TO ART: 714260-00Z, ANALYZER CODED MESSAGES CODE NUMBER: QCC 44 CAUSE/ACTION MESSAGE ON DISPLAY: UNABLE TO POSITION SAMPLE/ USE ANOTHER CARTRIDGE EXPLAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677782 ↗
• MalfunctionMar 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 02-MAR-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON AN 69 YEAR OLD FEMALE PATIENT WITH CAROTID ARTERY STENOSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDERGOING MEDICAL PROCEDURES SUCH AS CATHETERIZATION, CARDIAC SURGERY, SURGERY, ORGAN TRANSPLANT, AND DIALYSIS. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY.

  Patient problems: Transient Ischemic Attack

  MAUDE report 13940497 ↗
• MalfunctionFeb 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 17-JAN-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON AN 59 YEAR OLD FEMALE PATIENT WITH INFERIOR STEMI AND ONGOING CHEST PAIN. THE PATIENT WAS KNOWN TO BE ON METH, HAD GANGRENE AND THEIR CBC SHOWS HIGH PLATELETS OF 464. NEW INFORMATION WAS RECEIVED 20-JAN-2022 PROVIDING TIMES AND TESTING THAT WAS PERFORMED. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE INTENDED USE OF THE I-STAT CELITE ACTIVATED CLOTTING TIME (CELITE ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD, AND IS USEFUL FOR MONITORING PATIENTS RECEIVING HEPARIN FOR TREATMENT OF PULMONARY EMBOLISM OR VENOUS THROMBOSIS, AND FOR MONITORING ANTICOAGULATION THERAPY IN PATIENTS UNDERGOING MEDICAL PROCEDURES SUCH AS CATHETERIZATION, CARDIAC SURGERY, SURGERY, ORGAN TRANSPLANT, AND DIALYSIS. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY O

  Patient problems: Arteriosclerosis/ Atherosclerosis; Cardiomyopathy; Cellulitis; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Myocardial Infarction

  MAUDE report 13415717 ↗
• MalfunctionAug 31, 2021Off-Label Use; Incorrect, Inadequate or Imprecise Result or Readings; Off-Label Use; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12391588 ↗
• MalfunctionJun 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED MULTIPLE ACT STAROUTS ON A PATIENT IN THE CVOR WHILE PERFORMING A BYPASS. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CUSTOMER REPORTS THAT THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT IS OKAY. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE CUSTOMER STATES THAT THERE WAS NO IMPACT TO PATIENT MANAGEMENT AND THE PROCEDURE WAS SUCCESSFUL. INITIAL ANALYSIS SHOWED THAT RESULTS WERE GENERATED DURING THE PROCEDURE ON ANALYZERS (B)(4). ANALYZER (B)(4) DID NOT YIELD A RESULT AND WAS ONLY USED FOR ONE TEST DURING THE EVENT. CURRENTLY THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. HOWEVER, IT WAS DETERMINED A POTENTIAL DELAY HAS OCCURRED. ANALYZERS (B)(4) WERE REPLACED AT NO CHARGE TO THE CUSTOMER AND WILL BE INVESTIGATED SEPARATELY. THE INVESTIGATION IS UNDERWAY. REFERENCE ART: ART: 714374-000, INSTEAD OF RESULTS STARS APPEAR IN PLACE OF RESULTS IF THE ANALYZER DETECTS THAT THE SENSOR'S SIGN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922549 ↗
• MalfunctionMay 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Chest Pain

  MAUDE report 11807199 ↗
• MalfunctionFeb 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 18-FEB-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS ON AN (B)(6) YEAR OLD FEMALE PATIENT WITH CHEST PAIN. CUSTOMER CALLED STATING ANGIOMAX IS A TYPE OF ANTICOAGULATION THERAPY AND WANTED TO KNOW WHY IT IS NOT SUITABLE FOR USE WITH I-STAT ACTC CARTRIDGE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). PATIENT WAS ALSO ADMINISTERED 11ML OF AGIOMAX AT 1:07, 26ML PER HOUR AT 1:07, PLAVIX AT 1:08 AND 11ML OF ANGIOMAX AT 1:29. THE FACILITY WAS ADVISED THAT HEPARIN IS THE ONLY ANTICOAGULANT CLEARED FOR USE WITH I-STAT ACTC CARTRIDGE. USE OF OTHER ANTICOAGULANTS SUCH AS ANGIOMAX AND PLAVIX ARE CONSIDERED OFF LABEL USE. CUSTOMER REQUESTED DOCUMENTATION. CUSTOMER WAS PROVIDED LABELING PER INTENDED USE STATEMENT IN CTI SHEET: CELITE ACT ART: 714185-00Q. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Pain

  MAUDE report 11366801 ↗
• MalfunctionDec 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 12-NOV-2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED A RESULT OF 400 ON AN (B)(6)-YEAR OLD MALE PATIENT DURING A PROCEDURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: TIME: RESULT: HEPARIN DOSE: HEPARIN TIME: PROTAMINE: I-STAT; (B)(6) 2020; 15:32; N/A; 12000 UNITS; 15:32; N/A; I-STAT; (B)(6) 2020; 15:43; 245; N/A; N/A; N/A; I-STAT; (B)(6) 2020; 15:43; 400; N/A; N/A; N/A; I-STAT; B)(6) 2020; 16:00; N/A; N/A; N/A; 5MG; I-STAT; (B)(6) 2020; 16:01; N/A; N/A; N/A; 45MG; I-STAT; (B)(6) 2020; 16:10; 152; N/A; N/A; N/A; I-STAT; (B)(6) 2020; 16:10; 152; N/A; N/A; N/A. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Dizziness

  MAUDE report 10972333 ↗
• MalfunctionDec 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED A RESULT OF 148 ON AN (B)(6) YEAR OLD MALE PATIENT DURING A PROCEDURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TIME RESULT HEPARING DOSE: I-STAT (B)(6) 2020 16:44 395 N/A, I-STAT (B)(6) 2020 16:58 400 N/A, I-STAT (B)(6) 2020 17:11 148 N/A, N/A (B)(6) 2020 17:15 N/A 6000. NOTE: PATIENT ON HEPARIN DRIP PRIOR TO PROCEDURE. DOSE IS UNKNOWN. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. IT IS SUSPECTED THAT PATIENT RECEIVED PROTAMINE BETWEEN THE TWO LAST RESULTS. HOWEVER, THE CUSTOMER STATES THE PATIENT DID NOT RECEIVE PROTAMINE. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Pain; Nausea

  MAUDE report 10972283 ↗
• MalfunctionNov 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED A RESULT OF >1000 ON AN (B)(6) YEAR OLD FEMALE PATIENT PRESENTED FOR A TRANSAORTIC VALVE REPLACEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 10859694 ↗
• MalfunctionAug 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 07/15/2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED GENERATED TOTAL OF 11 STAR OUTS ON ONE PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. CUSTOMER STATES THAT THE INITIAL ACTC TEST AT 9:17AM WITH ACTC LOT R20040 HAD A RESULT OF 133 SECS AND THEN PATIENT WAS ADMINISTERED HEPARIN DOSAGE. THE 13TH AND FINAL ACTC TEST DONE AT 12:34PM HAD A RESULT OF 500 SECS USING ACTC LOT R20025A. ALL ACTC TESTS WERE DONE WITH FRESH PATIENT SAMPLES COLLECTED AS WHOLE BLOOD ARTERIAL SAMPLE TAKEN FROM RESERVOIR PORT OF BY-PASS PUMP AND TRANSFERRED BY PLAIN 3CC/18G SYRINGE TO CARTRIDGE. THE CUSTOMER STATED THAT THERE WERE NO ISSUES REPORTED WITH TESTING OTHER PATIENTS USING SAME ACTC LOTS R20025A AND ACTC LOT R20040. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. APOC HAS MADE SIX ATTEMPTS TO OBTAIN INFORMATION FROM THE CUSTOMER BUT TO NO AVAIL. ALTHOUGH THERE IS POTENTIAL FOR A SIGNIFICANT DELAY, A DELAY WAS NOT REPORTED, NOR IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER STATED THAT THE ISSUE IS SPECI

  Patient problems: No Information

  MAUDE report 10358071 ↗
• MalfunctionJun 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED 9 STAR OUTS (***) ON A PATIENT HAVING HEART SURGERY. THE CUSTOMER REPORTED GETTING BASELINE FOR PATIENT WHICH WAS THE FIRST RESULT, THEN 9 CONSECUTIVE STAROUTS WITH MULTIPLE DEVICES AND THEN ONE LAST RESULT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. APOC HAS DETERMINED THAT ALTHOUGH THERE WAS NO HARM TO THE PATIENT, THERE WAS A SIGNIFICANT DELAY. THE FACILITY ALSO STATES THAT THE LOT WAS RECEIVED ON (B)(6) 2020 AND THERE WERE NO ISSUES UNTIL THE THIS EVENT. THE CARTRIDGES WERE AT ROOM TEMPERATURE FOR A FEW DAYS PRIOR TO USE. THE TEMPERATURE IN ROOM DROPPED TO 59.50°F AND REPORTS THIS MAY BE THE REASON FOR THE STAROUTS. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Code Available

  MAUDE report 10159895 ↗
• MalfunctionJul 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Code Available

  MAUDE report 8817568 ↗
• MalfunctionJul 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Atrial Fibrillation

  MAUDE report 8759915 ↗
• MalfunctionMar 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A (B)(6) FEMALE PATIENT WITH CHEST PAIN. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THERE WAS NO BASELINE TESTS AND LIMITED PATIENT, DETAILS ABOUT THE EVENT. THERE IS NO EXPLANATION AS TO HOW THE RESULTS WOULD GO FROM 424 TO 188 SECONDS IN 8 MINUTES. THE CUSTOMER DID NOT PROVIDE PROTAMINE INFORMATION. IT IS SUSPECTED THAT PROTAMINE WAS ADMINISTERED BUT TIME AND DOSE WAS NOT REPORTED. THE CUSTOMER STATED THAT PROCEDURE WAS COMPLETED AS PLANNED AND THE PATIENT WAS DISCHARGED. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Pain

  MAUDE report 8456237 ↗
• MalfunctionOct 9, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT CELITE CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. TEST TIME: ACT: 0943, 551. 0954, 211. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

  Patient problems: No Information

  MAUDE report 6932461 ↗
• MalfunctionOct 9, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT CELITE CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE ((B)(6)).

  Patient problems: No Information

  MAUDE report 6932446 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992571. One submission often covers many models, so check the product and lot details in each record.

• Z-1341-2011 · Dec 3, 2010 · Terminated
  Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation the
• Z-0399-2011 · Oct 6, 2010 · Terminated
  i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
• Z-0813-2010 · Aug 18, 2009 · Terminated
  Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
• Z-0912-05 · Mar 16, 2005 · Terminated
  i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.