i-STAT 03P85-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10054749002266), received between Apr 7, 2017 and Sep 15, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 28-AUG-2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT LACTATE RESULTS ON A (B)(6) YEAR OLD MALE COVID 19 PATIENT WITH RENAL FAILURE AND ON DIALYSIS AND HAS DKA AND POSSIBLE ISCHEMIC BOWEL. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, (B)(6) 2020, DATE: 22:10, TIME: 1.24, RESULT LOCATION: FIELD HOSPITAL; I-STAT, (B)(6) 2020, 02:00, 1.14, FIELD HOSPITAL; I-STAT, (B)(6) 2020, 07:15, 4.86, FIELD HOSPITAL; I-STAT, (B)(6) 2020, IN, 6.67, FIELD HOSPITAL; I-STAT, (B)(6) 2020, IN, 6.92, FIELD HOSPITAL; I-STAT, (B)(6) 2020, IN, 1.0, EMERGENCY ROOM. 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 LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE PATIENT WAS GIVEN SEVERAL LITERS OF FLUID BETWEEN THE READING OF 6.67 AND 1.0. THERE WERE MULTIPLE REQUESTS FOR INFORMATION REGARDING THE FLUID AND DOSE GIVEN TO THE PATIENT TO BETTER UNDERSTAND POTENTIAL DISCREPANT R

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Renal Failure

  MAUDE report 10534973 ↗
• MalfunctionSep 10, 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 I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PCO2, PO2 & PH RESULTS ON A PATIENT WITH COVID19. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (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 LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. IT IS SUSPECTED THAT PATIENT MAY HAVE BEEN OVER VENTILATED CAUSING ERRONEOUS RESULTS. HOWEVER, THERE WERE MULTIPLE REQUESTS FOR INFORMATION REGARDING VENTILATION BUT TO NO AVAIL. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10513849 ↗
• MalfunctionSep 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES (LOT# D18176A AND D18129) THAT YIELDED SUSPECTED DISCREPANT LACTATE RESULTS ON AN (B)(6) FEMALE AUTO TRAUMA PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE. (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. BOTH I-STAT LOTS ARE CONSISTENT WITH EACH OTHER AND THERE WAS NO REPEAT ON THE LAB INSTRUMENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 7850125 ↗
• MalfunctionAug 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES (LOT# D18176A) THAT YIELDED SUSPECTED DISCREPANT RESULTS ON AN (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 7826115 ↗
• MalfunctionAug 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON AN (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 7826113 ↗
• MalfunctionAug 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES (LOT# D18073) THAT YIELDED SUSPECTED DISCREPANT RESULTS ON AN (B)(6) YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 7826111 ↗
• MalfunctionAug 1, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON AN (B)(6) MALE PATIENT WHO HAD FALLEN AT HOME AND WAS FOUND LAYING ON THE FLOOR OUTSIDE THE BATHROOM. PER THE PATIENT AND FAMILY, HE LAID ON THE FLOOR FOR 3 DAYS, BEFORE BEING FOUND BY FAMILY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Dehydration; Fall; Pain

  MAUDE report 7738302 ↗
• MalfunctionJan 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT LACTATE RESULT ON A (B)(6) MALE PATIENT WITH ACUTE RESPIRATORY FAILURE AND OVERDOSE. THERE WAS NO ADDITIONAL 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 INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Overdose; Respiratory Failure

  MAUDE report 7222801 ↗
• MalfunctionDec 22, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT LACTATE RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (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)(4).

  Patient problems: No Information

  MAUDE report 7141646 ↗
• MalfunctionDec 22, 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 CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT LACTATE RESULT ON A (B)(6) YEAR OLD MALE PATIENT WITH EPIGASTRIC ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (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)(4).

  Patient problems: Abdominal Pain

  MAUDE report 7141642 ↗
• MalfunctionAug 18, 2017False Negative Result; False Negative Result

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE/TIME COLLECTED , TEST TIME, PH, METHOD, SAMPLE, SAMPLE TYPE: (B)(6) 2017, 19:55PM, 20:03, 7.067 I-STAT, A , WB/VENOUS AND (B)(6) 2017, 20:35PM, 21:3,5 7.32 ABL800, B , WB/VENOUS. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 6805222 ↗
• MalfunctionJul 28, 2017False Positive Result; False Positive Result

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT PRESENTED IN THE ED ON A DIABETIC EMERGENCY. THE PATIENT WAS TREATED AND DISCHARGED. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. LAB ANALYZER MAKE AND MODEL # ARE UNKNOWN. THE CUSTOMER STATES THAT THE WAS NO HARM TO THE PATIENT, PATIENT WAS TREATED ON THE LAB ANALYZER RESULT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: (B)(6) 2017, TIME: 1635, METHOD: I-STAT, RESULT: 7.1; (B)(6) 2017 1705, LAB, 2.8. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 6752562 ↗
• MalfunctionJul 28, 2017False Positive Result; False Positive Result

  ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT ADMITTED TO THE PICU FOR INFANTILE SPASMS. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. LAB ANALYZER MAKE AND MODEL # ARE UNKNOWN. THE CUSTOMER STATES THAT THE WAS NO HARM TO THE PATIENT, PATIENT WAS TREATED ON THE LAB ANALYZER RESULT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: (B)(6) 2017, TIME: 1003, METHOD: I-STAT, RESULT: 8.0. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 6752561 ↗
• MalfunctionJun 23, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6)2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A (B)(6) YEAR OLD MALE PATIENT WITH ALTERED CONDITIONS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: METHOD: SAMPLE: TIME: PH: PCO2: PO2: HCO3: BE: SAT: TCO2: LAC: (B)(6)2017, I-STAT, A, 01:44, 6.99, 41.9, 71, 10.1, -21, 80%, 11, 0.85. (B)(6)2017, I-STAT, B, 02:03, 7.38, 41.3, 82, 24.5, -1.0, 96%, 26, 0.81. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 6665793 ↗
• MalfunctionApr 7, 2017False Negative Result; False Negative Result

  ON 03/28/2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT DURING POST OP. THE CUSTOMER STATES THAT THE RESULTS REPORTED DID NOT MATCH THE TREND OF THE PATIENT ON THE FIRST TEST. THE CUSTOMER REPORTS THAT THE NURSE RE-TESTED AND THE RESULTS GENERATED MATCHED THE TREND OF THE PATIENT. THE PATIENT WAS BEING TESTED EVERY TWO HOURS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. EVENT DATE: (B)(6) 2017, COLLECT: 20:10, TEST: 20:10, SAMPLE: A, PH: 7.193, PCO2: 39.4, PO2: 93, HCO3: 15.2, BE: -13, SO2: 95%, LAC: 0.77, TCO2:16; (B)(6) 2017, 20:10, 20:14, A, 7.469, 38.2, 104, 24.0, -1, 98%, 0.83, 25. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 6471716 ↗