i-STAT 03P79-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10054749000071), received between Oct 9, 2017 and Sep 13, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (23 reports).

19 other recalls cover devices cleared under the same FDA submission (K940918); 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. 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 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 POTASSIUM RESULT OF 2.0 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD RESULT SAMPLE ALINITY 2.0 MMOL/L A LAB 3.5 MMOL/L A DATE, COLLECTION AND TEST TIMES, PRODUCT LOT INFORMATION WERE NOT PROVIDED, REQUESTED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740196 ↗
• MalfunctionOct 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PCO2 RESULTS ON A MALE PATIENT WITH SEVERE ACIDOSIS. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. DATE: (B)(6) 2022. TIME: 13:59 14:27. NA: 126 MMOL/L 125MMOL/L . K: 8.4 8.2 MMOL/L . CL: 100 MMOL/L 104 MMOL/L . TCO2 6 <5. UREA: 19.6 MMOL/L 19.5 MMOL/L. HCT: 42%PCV 38% PCV. PH: 6.772 6.833 . PCO2: 4.55 KPA 2.33 KPA. HCO3: 5.0 MMOL/L 2.9 MMOL/L. BEECF:-30 <-30 . ANGAP:30 MMOL/L <> . HB: 143 G/L 129 G/L . 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.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Respiratory Acidosis

  MAUDE report 15680010 ↗
• MalfunctionJun 7, 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 EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT SODIUM RESULT OF 129 MMOL/L ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD, DATE, RESULT(NA); I-STAT, (B)(6) 2022, 129 MMOL/L; LAB, (B)(6) 2022, 150 MMOL/L; TEST/COLLECTION TIMES NOT PROVIDED. CARTRIDGE LOT# INFORMATION IS ALSO UNKNOWN AT THE TIME OF THIS REPORT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622929 ↗
• MalfunctionFeb 1, 2022Incorrect, 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 EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF >9.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. EC8+; (B)(6) 2022; @12:24 AM; K+ 2.8 MMOL/L. EC8+; (B)(6) 2022; @5:19 AM; K+ >9 MMOL/L. EC8+; (B)(6) 2022; @10:39 AM; K+ 3.2 MMOL/L. THE CUSTOMER STATED THAT THEY SUSPECT BUT CANNOT CONFIRM THAT THE RESULT OF EC8+, (B)(6) 2022 @ 5:19 AM, K+ >9 MMOL/L WAS RUN ON A SAMPLE COLLECTED IN EDTA TUBE. CUSTOMER IS UNABLE TO PROVIDE ANY CARTRIDGES TO RETURN FOR INVESTIGATION FOR EC8+ LOT K21158 EXPIRED (B)(6) 2022. CUSTOMER IS AWARE THEY WERE USING EXPIRED CARTRIDGES AT THE TIME OF THE EVENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415722 ↗
• MalfunctionOct 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625502 ↗
• MalfunctionSep 14, 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 I-STAT EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT SODIUM RESULT OF 139 MMOL/L ON DOG. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD, DATE, TESTED, RESULT (UNITS) SAMPLE: (B)(6). (B)(6): I-STAT REFERENCE RANGE FOR SODIUM (138-146 MMOL/L). 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. CUSTOMER STATES THE PATIENT DIED ON (B)(6) 2021 AT 6:30PM DUE TO CARDIAC ARREST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467358 ↗
• MalfunctionJan 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 18-DEC-2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 9.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE ER DOCTOR RECEIVED AN INITIAL POTASSIUM VALUE OF 9.0, THE DOCTOR LATER RERAN A SAMPLE AND RECEIVED 6.0. THERE ARE NO TIMES, DATES, OR PATIENT REPORTED WITH THE COMPLAINT. CUSTOMER HAS BEEN CONTACTED FOR INFORMATION BUT TO NO AVAIL. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154428 ↗
• MalfunctionFeb 5, 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 EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 7 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, K RESULTS: 7 MMOL/L. LAB, 4 MMOL/L. COLLECT, TEST TIMES, AND CARTRIDGE LOT INFORMATION WAS NOT PROVIDED. 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 9673199 ↗
• MalfunctionFeb 5, 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 EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF 6 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, K RESULTS: 6 MMOL/L. LAB, 3 MMOL/L. COLLECT, TEST TIMES, AND CARTRIDGE LOT INFORMATION WAS NOT PROVIDED. 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 9673198 ↗
• MalfunctionFeb 5, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Information

  MAUDE report 9673197 ↗
• MalfunctionMay 16, 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PH (7.659) AND BE (6MMOL/L) RESULTS ON AN (B)(6) MALE PATIENT WITH TENTATIVE DIAGNOSIS OF PNEUMONIA. THE CUSTOMER STATES THAT THE BE RESULT REVEALS METABOLIC ALKALOSIS, BUT HCO3 RESULT IS NORMAL. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE WERE NO TEST/COLLECTION TIMES REPORTED. 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 REPEAT ON I-STAT OR ALTERNATE METHOD. THE CUSTOMER STATES THAT RESULTS ARE NOT CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information; Pneumonia

  MAUDE report 8615337 ↗
• MalfunctionApr 23, 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT BUN AND POTASSIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: (B)(6) 2019, BUN: 124 MG, POTASSIUM: 79 MMOL/L, SAMPLE: A (SUSPECT INCORRECT RESULT. POSSIBLY 7.9). I-STAT, (B)(6) 2019, 18 MG, 4.4 MMOL/L, B. COLLECT AND TEST TIMES NOT PROVIDED. 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 PATIENT INFORMATION. THE CUSTOMER STATES THAT THE POTASSIUM RESULT WAS 79 MMOL/L. HOWEVER, THE RESULT APPEARS TO BE INCORRECT. PER I-STAT SYSTEM MANUAL ART: 714174-00P, THE REPORTABLE RANGE FOR POTASSIUM IS 2.0 - 9.0 MM/L. THE CUSTOMER HAS REQUESTED THE ANALYZER BE REPLACED, AS THE ERRORS HAVE OCCURRED WITH TWO LOTS OF CARTRIDGES. THE ERRORS IN QUESTION HAVE NOT BEEN CONFIRMED AND THE PRODUCT HAS NOT BEEN REPLACED. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 8540828 ↗
• MalfunctionApr 4, 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT PCO2 RESULT OF 67.9 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 CUSTOMER STATES THEY USED A LITHIUM HEPARIN TUBE AS A COLLECTION DEVICE, BUT ONLY FILLED THE TUBES UP TO 50% OF RECOMMENDED LIMIT SET BY MANUFACTURER. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 8484729 ↗
• MalfunctionMar 14, 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT WITH RESPIRATORY DISTRESS. 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. CUSTOMER HAS NOT PROVIDED, CARTRIDGE LOT, OR PATIENT INFORMATION AS REQUESTED. THE INVESTIGATION ON HOLD AT THIS TIME UNLESS CARTRIDGE LOT INFORMATION IS OBTAINED.

  Patient problems: Respiratory Distress

  MAUDE report 8419848 ↗
• MalfunctionMar 6, 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 EC8+ 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. PER I-STAT SYSTEM MANUAL, ART: 714372-00N, HEMOLYSIS CAN CAUSE K+ >9.0 MMOL/L. HOWEVER, SAMPLE HANDLING WAS NOT CONFIRMED AT THE TIME OF THIS REPORT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Code Available

  MAUDE report 8394490 ↗
• MalfunctionDec 27, 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT WITH HISTORY OF ANEMIA, SECONDARY TO CHRONIC RENAL FAILURE. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CUSTOMER REPORTS AN I-STAT VALUE OF 15% PCV. AN INITIAL MANUAL PCV RESULT WAS 36%, A SECOND MANUAL PCV RESULTS WAS 45%. DATES AND TIMES OF THE TEST WERE NOT DOCUMENTED. 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. IT IS SUSPECTED THAT THE MANUAL PCV DETERMINED MAY BE A HEMOGLOBIN RESULT. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO SUPPORT THE CAUSE. NOR IT IS CLEAR AT THIS TIME WHAT "MANUAL METHOD" WAS BEING USED. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Anemia; Renal Failure

  MAUDE report 8200845 ↗
• MalfunctionSep 19, 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 EC8+ 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. IT IS SUSPECTED THAT THE PATIENT SAMPLE WAS POTENTIALLY HEMOLYZED. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO SUPPORT THE CAUSE. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Information

  MAUDE report 7888762 ↗
• 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) FEMALE PATIENT WITH A COUGH. 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. THE INVESTIGATION IS UNDERWAY.

  Patient problems: No Code Available

  MAUDE report 7738421 ↗
• MalfunctionNov 6, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT WITH CHEST PAIN. THE PATIENT WAS TRANSPORTED TO THE CATH LAB BASED ON THE LAB K+ RESULT. THERE WERE NO CLINICAL DECISIONS MADE BASED ON THE I-STAT RESULT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). BASED ON THE HCT RESULT OF <15% ALONG WITH THE SUSPECTED DISCREPANT RESULT, HYMOLOSYS IS THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chest Pain

  MAUDE report 7004138 ↗
• MalfunctionOct 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 EC8+ CARTRIDGES THAT YIELDED HIGH RESULTS FOR CHLORIDE AND POTASSIUM ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). TEST/COLLECTION TIMES ARE UNKNOWN. 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 6941410 ↗
• MalfunctionOct 10, 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 EC8+ CARTRIDGES THAT YIELDED LOW RESULTS FOR K ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. I-STAT RESULTS RUN ON (B)(6) 2016 AT 09:10. VETSCAN WHOLE BLOOD SAMPLE RUN ON (B)(6) 2016 AT 08:39. VETSCAN SERUM SAMPLE RUN ON (B)(6) 2016 AT 08:17. K+ ON I-STAT OF 2.7 MMOL/L VS K+ ON VETSCAN WB OF 5.8 MMOL/L (HEMOLYZED 2+), VETSCAN SERUM OF 6.2 MMOL/L. NA+ ON I-STAT OF 146 MMOL/L VS NA+ ON VETSCAN WB OF 143 MMOL/L, VETSCAN SERUM OF 137 MMOL/L. BUN ON I-STAT OF 3 MG/DL VS BUN ON VETSCAN WB OF 5 MG/DL, VETSCAN SERUM OF 5 MG/DL. GLU ON I-STATOF 85 MG/DL VS GLU ON VETSCAN WB OF 74 MG/DL, VETSCAN SERUM OF 88 MG/DL. 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 6938649 ↗
• 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 EC8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT SODIUM AND POTASSIUM RESULTS ON A PATIENT (DOG). THE CUSTOMER STATED THAT THE PATIENT PASSED AWAY AT A LATER DATE BEFORE RETESTING. THE CAUSE OF DEATH IS UNKNOWN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: TIME: METHOD: NA+ RESULT MEQ/L: K+ RESULT MEQ/L: SAMPLE: (B)(6) 2016, 10:16AM, I-STAT, 118 MEQ/L, > 9MEQ/L , A. (B)(6) 2016, 11:15AM, VS2, UNREADABLE, 3.7 MEQ/L, B. 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 6932290 ↗
• 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 EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT SODIUM RESULT ON A PATIENT. PATIENT IS DIABETIC THAT IS BEING MANAGED FOR KETOSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NA+ I-STAT OF 133 MMOL/L VS ANTECH OF 145 MEQ/L. OTHER RESULTS: K+ ISTAT OF 5.2 MMOL/L VS ANTECH OF 5.2MEQ/L. CL ISTAT OF 108 MMOL/L VS ANTECH OF 107 MEQ/L. BUN OF 6 MG/DL FOR BOTH. GLUCOSE ISTAT OF 435 MG/DL VS ANTECH OF 132 MG/DL. HCT ISTAT OF 41% VS ANTECH OF 44%. HGB ISTAT OF 13.9 G/DL VS ANTECH OF 14.4 G/DL. 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 6932281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940918. One submission often covers many models, so check the product and lot details in each record.

• Z-2000-2026 · Apr 1, 2026 · Open, Classified
  i-STAT EG6+ cartridge; List Number: 03P77-25;
• Z-1999-2026 · Apr 1, 2026 · Open, Classified
  i-STAT EG7+ cartridge; List Number: 03P76-25;
• Z-2582-2025 · Aug 21, 2025 · Open, Classified
  i-STAT CG4+ cartridge (white). List Number: 03P85-25.
• Z-0881-2021 · Dec 22, 2020 · Terminated
  Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary wh
• Z-0880-2021 · Dec 22, 2020 · Terminated
  Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capill
• Z-0615-2019 · Sep 13, 2018 · Terminated
  Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749
• Z-1306-2014 · Jan 1, 2014 · Terminated
  i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based d
• Z-2133-2012 · Jan 1, 2011 · Terminated
  I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, c
• Z-0595-2011 · Sep 20, 2010 · Terminated
  i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and
• Z-0593-2011 · Sep 20, 2010 · Terminated
  i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-st
• Z-0596-2011 · Sep 20, 2010 · Terminated
  Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the
• Z-0594-2011 · Sep 20, 2010 · Terminated
  FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i
• Z-0929-2011 · Aug 3, 2010 · Terminated
  i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantificati
• Z-0930-2011 · Aug 3, 2010 · Terminated
  i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide pa
• Z-1793-2010 · Feb 5, 2010 · Terminated
  i-STAT EG7+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood

…and 4 more.