i-STAT 09P31-26Recalls & reported problems
Abbott Point Of Care Inc. · Cartridge, Chem8+ · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Abbott i-STAT cartridge measures blood values. The 55 reports describe readings that differed from laboratory tests, often for potassium. There were no deaths or injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10054749005519), received between Jun 10, 2020 and Sep 9, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (56 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings56
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- High Blood Pressure/ Hypertension3
- Pain3
- Confusion/ Disorientation2
- Elevated Ketones/ Diabetic Ketoacidosis2
- Heart Failure/Congestive Heart Failure2
- Unspecified Heart Problem2
- Abdominal Pain1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696492 ↗MalfunctionSep 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THIS CORRECTION IS BASED ON COMMUNICATION RECIEVED ON 28-JAN-2025 FROM DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES: MDR REPORT (#2245578-2024-00173) WHICH HAS AN INCORRECT PRODUCT CODE AND 510(K) NUMBER. IN THIS REPORT YOU STATE THAT "ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PRODUCT THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A PATIENT. METHOD RESULT I-STAT: 31, LAB:11" CURRENTLY, THE REPORT (#2245578-2024-00173) LISTS PROCODE: KHP. HOWEVER, THIS REPORT IS FOR HEMATOCRIT TEST AND THE PROCODE NEEDS TO BE CORRECTED. ADDITIONALLY, IT APPEARS THAT THE CURRENT REPORT LISTS THE INCORRECT 510(K) (K200492 WHICH IS NOT FOR HEMATOCRIT TESTING) TOO. YOU MAY USE "510(K) PREMARKET NOTIFICATION" DATABASE TO SEARCH FOR THE CORRECT PROCODE AND 510(K) NUMBER. PLEASE SUBMIT A SUPPLEMENT TO CORRECT THE MDR (#2245578-2024-00173) WITH INCORRECT PROCODE AND 510(K). PLEASE PROVIDE YOUR RESPONSE TO ABOVE REQUEST BY FEBRUARY 5, 2025, AT 5:00PM (EASTER TIME).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179375 ↗MalfunctionApr 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 02-APR-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON AN 70 YEAR OLD MALE PATIENT WITH AN ACUTE KIDNEY INJURY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED CREA(MG/DL) I-STAT (B)(6) 2024 13:43 13:43 9.6 LAB (B)(6) 2024 21:10 22:20 6.7 AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19073946 ↗MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionDec 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionNov 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 09-NOV-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A 97 YEAR OLD FEMALE PATIENT WITH SHORTNESS OF BREATHE, & WHEEZING. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD, DATE, TESTED, RESULT, SAMPLE; AU, (B)(6) 2023, 01:20, 6.7 MMOL/L, A. I-STAT; (B)(6) 2023, 02:49, 4.1 MMOL/L, B; AU, (B)(6) 2023, 20:28, 7 MMOL/L , C; I-STAT, (B)(6) 2023, 20:22, 4.2 MMOL/L, D. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: Unspecified Respiratory Problem; Wheezing
MAUDE report 18131474 ↗MalfunctionOct 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A 65 YEAR OLD MALE PATIENT DIAGNOSED WITH CORONARY ARTERY DISEASE (CAD). THE CUSTOMER STATED THAT THE PROCEDURE CANCELED, PATIENT WAS TRANSPORTED VIA AMBULANCE TO ER AND AFTER HOSPITAL RESULT, THE PATIENT RESCHEDULED FOR THE PROCEDURE, THE SAME DAY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; DATE: (B)(6) 2023; COLLECTED: 9:00; TESTED: 9:06; RESULTS: 6.1 MEQ/L. METHOD: I-STAT; DATE: (B)(6) 2023; COLLECTED: 9:11; TESTED: 9:14; RESULTS: 7.4 MEQ/L. METHOD: LAB; DATE: (B)(6) 2023; COLLECTED: NI; TESTED: 10:17; RESULTS: 4.2 MEQ/L. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17956843 ↗MalfunctionOct 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT OF >9 MMOL/L ON A 55 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS SAMPLE I-STAT (B)(6) 2023 10:19 10:19 >9 MMOL/L SAMPLE A. LAB (B)(6) 2023 10:40 10:40 3.8 MMOL/L SAMPLE B. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17859644 ↗MalfunctionSep 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT OF >9 MMOL/L ON A FEMALE PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD RESULT SAMPLE. I-STAT >9.0 MMOL/L A. ANTECH 4.3 MEQ/L A. TEST/COLLECTION TIMES NOT AVAIL. . PRODUCT LOT# INFORMATION NOT PROVIDED BUT REQUESTED. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773148 ↗MalfunctionJul 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 30-JUN-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 8.2 & 7.1 ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: SAMPLE: DATE: TESTED: BUN: CREA: SAMPLE: I-STAT, WB, (B)(6) 2023, 1527, 140MG/DL , 8.2 MG/DL, A. LAB , SERUM, (B)(6) 2023, 1527, 28 MG/DL, 1.4 MG/DL, A. I-STAT, WB, (B)(6) 2023, 1609, 126 MG/DL, 7.1 MG/DL, B. LAB, SERUM, NI, NI, 29 MG/DL, 1.5 MG/DL, A. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. TWO I-STAT RESULTS ARE CONSISTENTLY HIGH ON TWO DIFFERENT SAMPLES. IT IS SUSPECTED BASED ON THE ELEVATED I-STAT RESULTS THAT THE PATIENT MAY BE ON HYDROXYUREA AND THE CAUSE FOR THE ELEVATED RESULTS. HOWEVER, THERE WAS NO CONFIRMATION OF THE PATIENT'S MEDICATIONS AT THE TIME OF THIS REPORT. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17346198 ↗MalfunctionJul 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 29-JUN-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS OF 9 MMOL/L ON A FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: (B)(6) 2023, K: 9 MMOL/L, SAMPLE: A; I-STAT , (B)(6) 2023, 9 MMOL/L , A; I-STAT , (B)(6) 2023 , 3.8 MMOL/L , A; LAB , (B)(6) 2023 , 5 MMOL/L , A. TEST/COLLECTION TIMES NOT AVAIL. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17297859 ↗MalfunctionJun 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT HEMATOCRIT RESULT OF 22.7% ON A MALEPATIENT WITH ALTERED LEVEL OF CONSCIOUSNESS, DIAPHORETIC/TACHYPNEIC. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD:I-STAT,LAB; DATE: 05-JUN-2023, 05-JUN-2023; TIME: 0337,0456; HB:7.1G/DL 14.2 G/DL, HCT :22.7%, 43.6%; SAMPLE: A, B; AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: Altered State of Consciousness
MAUDE report 17161732 ↗MalfunctionApr 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 23-MAR-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM & HEMATOCRIT RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2023, COLLECTED: 06:59, TESTED: 07:04, HCT: 22, K: 2.8, SAMPLE: WB; DXH900, (B)(6) 2023, 06:59, 07:24, 43.2, NI, WB; BECKMAN, (B)(6) 2023, 06:59, 07:24, NI, 4.1, WB. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16677789 ↗MalfunctionJan 17, 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 CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A 75 YEAR OLD MALE PATIENT PRESENTED WITH WEAKNESS, LETHARGIC, & COUGHING. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD:I-STAT, DATE: (B)(6) 2023 09:39, COLLECTED: 9:39, TESTED: 49.0, HCT(PVC):16.7, HB(G/DL): A, SAMPLE: A; METHOD: LAB, DATE: (B)(6) 2023 09:39, COLLECTED: 09:39, TESTED: 26.4, HCT(PVC): UNK, HB(G/DL): 7.8 G/DL, SAMPLE: A. 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: Cough; Muscle Weakness/Atrophy
MAUDE report 16183702 ↗MalfunctionJan 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 11-JAN-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A 67 YEAR OLD MALE PATIENT PRESENTED FOR SHOULDER SURGERY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED HB (G/DL) HCT(G/DL) SAMPLE LAB ON (B)(6) 2022, 06:35 07:11 CANCELLED VENOUS #1, I-STAT ON (B)(6) 2022, 07:35 07:35 15.3 45 VENOUS #2, LAB ON (B)(6) 2022, 07:35 08:32 4.8 17.3 VENOUS #2, LAB ON (B)(6) 2022, 10:43 11:23 4.4 16.1 VENOUS #3, LAB ON (B)(6) 2022, 11:55 12:09 4.2 15.4 FINGERSTICK #1. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 16183639 ↗MalfunctionDec 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionOct 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 27-SEP-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULT OF 37% ON A 17 MONTH OLD FEMALE PATIENT WITH AN INTRACRANIAL HEMORRHAGE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (METHOD; COLLECT/TESTED; TIME; HGB(MMOL/L); HCT(% PCV); SAMPLE) I-STAT 1, (B)(6) 2022, 02:04, 9.2, 37, A. BECKMAN, (B)(6) 2022, NI, 6.4, 18.8, A. 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 INVESTIGATION IS UNDERWAY.
Patient problems: Hematoma; Intracranial Hemorrhage
MAUDE report 15606013 ↗MalfunctionOct 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 10-OCT-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULT OF 50% ON A PATIENT WITH CARDIAC ARREST. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (METHOD; COLLECT/TESTED; TIME; HGB(MMOL/L); HCT(% PCV); SAMPLE) I-STAT 1, (B)(6) 2022, 1:05, 17, 50, A. BECKMAN, (B)(6) 2022 , NI , 11, 34, A. 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 INVESTIGATION IS UNDERWAY.
Patient problems: Cardiac Arrest; Tachycardia
MAUDE report 15606005 ↗MalfunctionOct 14, 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 CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREA RESULT OF 3.6 MG/DL AND BUN RESULT OF 24 MG/DL ON A 58 YEAR OLD FEMALE PATIENT WITH TYPE II DIABETES, AND PRIMARY HYPERTENSION. 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 LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.
Patient problems: Dizziness; Elevated Ketones/ Diabetic Ketoacidosis; High Blood Pressure/ Hypertension; Nausea
MAUDE report 15605992 ↗MalfunctionOct 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 27-SEP-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULT OF <15% ON A 65 YEAR OLD MALE PATIENT WITH HYPERKALEMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (METHOD; COLLECT/TESTED; TIME; HGB(MMOL/L); HCT(% PCV); SAMPLE) I-STAT 1, (B)(6) 2022, 0:25, <>, <15, A. BECKMAN, (B)(6) 2022, NI, 9.3, 30.3, A. 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 INVESTIGATION IS UNDERWAY.
Patient problems: Hyperkalemia; Respiratory Failure
MAUDE report 15605979 ↗MalfunctionSep 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 CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT IONIZED CALCIUM RESULTS OF 2.4 & 2.17 MMOL/L 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. I-STAT, (B)(6) 2022, 2.4 MMOL/L. I-STAT, (B)(6) 2022, 2.17MMOL/L. I-STAT, (B)(6) 2022, 1.19MMOL/L (NORMAL, USING ANOTHER LOT). 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 INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15494001 ↗MalfunctionSep 15, 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 CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREA (14.3), AND POTASSIUM (6.5) RESULTS ON A 44 YEAR OLD FEMALE 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 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 15427999 ↗MalfunctionSep 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 06-SEP-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES AND I-STAT SN (B)(4) THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 2.5 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. ANALYZER SN (B)(4) IS BEING REPLACED AT NO CHARGE AND WILL BE INVESTIGATED SEPARATELY. (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. THE INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15382987 ↗MalfunctionAug 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 CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS OF 0.3 & 104 MG/DL ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CREA, MG/DL 0.3 AND 1.4. 0.5-1.3 REF. 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 INVESTIGATION IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15279105 ↗MalfunctionAug 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 22-AUG-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A 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 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 15279049 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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