i-STAT 03P78-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10054749002280), received between Dec 11, 2017 and Nov 3, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 26-OCT-2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PCO2 RESULT OF 9.5 MMHG ON A (B)(6) YEAR OLD MALE WITH ASTHMA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: PH: PCO2: PO2: BE,B: HCO3: TCO2: SO2: FIO2; I-STAT (B)(6) 2020 16:12 7.247 9.5MMHG 94MMHG 20 4.1MMOL/L <5MMOL/L 96% 36; I-STAT (B)(6) 2020 16:12 7.254 63.1MMHG 103MMHG 1 27.9MMOL/L 30 MMOL/L 97% N/A. 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: Asthma

  MAUDE report 10779245 ↗
• MalfunctionMar 20, 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 I-STAT G3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PH, PCO2, AND HC03 ON A (B)(6) MALE PATIENT THAT WAS PRESENTED LETHARGIC. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE CUSTOMER STATED THAT PH, PCO2, AND HC03 RESULTS ARE UNEXPECTED. HOWEVER, THE PH RESULT OF 7.228 MMHG APPEARED TO BE THE DISCREPANT RESULT AND POTENTIALLY RELATED TO SAMPLE HANDLING ALTHOUGH NOT CONFIRMED AT THIS TIME. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY.

  Patient problems: Lethargy

  MAUDE report 8435832 ↗
• MalfunctionDec 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 11/26/2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT G3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PO2 RESULT OF 41MMHG ON A (B)(6) YEAR OLD MALE PATIENT WITH DIABETES AND HYPERTENSION. THE CUSTOMER REPEATED THE TEST USING ANOTHER LOT AND RESULTS WERE AS EXPECTED. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD; DATE; COLLECTED; TESTED; PO2; SAMPLE: I-STAT (B)(6) 2018, 0505, 0511, 41 MMHG, A; I-STAT (B)(6) 2018, 0505, 051,1 72 MMHG, A. REF RANGE 80-100 MMHG. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE CUSTOMER STATED THAT ONLY PO2 RESULTS ARE UNEXPECTED, AND PH RESULTS ARE ACCEPTABLE. HOWEVER, THE ISSUE APPEARS TO BE RELATED TO SAMPLE HANDLING ALTHOUGH NOT CONFIRMED AT THIS TIME. THE REPORTING DECISION WAS BASED ON INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; High Blood Pressure/ Hypertension

  MAUDE report 8156745 ↗
• MalfunctionJun 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 G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A PATIENT. 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 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 7651939 ↗
• MalfunctionJun 20, 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 G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A MALE INFANT PATIENT. AT THE TIME OF THE INITIAL CALL THERE WERE NO I-STAT RESULTS AVAILABLE. NEW INFORMATION WAS RECEIVED ON 06/17/2018 AND I-STAT RESULTS BECAME AVAILABLE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE. (B)(6). SAMPLE TIMES ARE NOT AVAILABLE. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. IT IS SUSPECTED THAT THE RESULTS PROVIDED ARE NOT FROM THE SAME PATIENT. HOWEVER, THIS IS NOT CONFIRMED AT THE TIME OF THIS REPORT. 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 7618531 ↗
• MalfunctionApr 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 G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) YEAR OLD MALE PATIENT WITH SPINAL CORD INJURY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE. METHOD: I-STAT, DATE: (B)(6) 2018, TESTED: UNK, RESULT 9.5MMHG (RESULT IN QUESTION); I-STAT, (B)(6) 2018, 1514, 27.4MMHG. 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: Spinal Cord Injury

  MAUDE report 7463820 ↗
• MalfunctionApr 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 G3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT WITH SHORTNESS OF BREATH, COUGH WORSENING. PATIENT REPORTED INTERMITTENT FEVERS WHICH HAVE BEEN SUBJECTIVE. (B)(6) NASAL CONGESTION. (B)(6) CHEST TIGHTNESS. COURSE/DURATION OF SYMPTOMS IS CONSTANT AND WORSENING. 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 INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Tightness/Pressure; Chronic Obstructive Pulmonary Disease (COPD); Fever; Respiratory Distress; Respiratory Failure

  MAUDE report 7404866 ↗
• MalfunctionDec 11, 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 G3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT ON A (B)(6) YEAR OLD MALE PATIENT WITH ATHEROSCLEROSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Atherosclerosis

  MAUDE report 7106857 ↗