i-STAT 03P82-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10054749000101), received between Oct 7, 2017 and Mar 31, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 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 E3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT HEMATOCRIT RESULT OF 33% PCV ON AN (B)(6) MONTH/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 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 9902582 ↗
• MalfunctionJan 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Cataract

  MAUDE report 9642594 ↗
• MalfunctionOct 17, 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 E3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULTS OF >9.0 ON A (B)(6) YEAR OLD MALE PATIENT PRESENTED FOR CARDIAC SURGERY. NURSE STATED THAT DUE TO K RESULTS OF >9.0 MMOL/L, PATIENT WAS GIVEN 5 UNIT OF INSULIN AND AMP OF D50. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL, AND THE K RESULT THERE WAS 4.0 MMOL/L (TEST TIME: UNKNOWN). THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: 08-OCT-2019, TESTED: 08:25, RESULT: >9.0 MMOL/L. I-STAT, 08-OCT-2019, 08:XX, >9.0 MMOL/L. LAB, 08-OCT-2019, UNK, 4.0 MMOL/L. COLLECTION TIMES NOT PROVIDED. LAB COLLECTION AND TEST TIMES ARE UNKNOWN. 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 Information

  MAUDE report 9202879 ↗
• MalfunctionSep 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Information

  MAUDE report 9077650 ↗
• MalfunctionJul 30, 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 E3+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: 07/11/2019, TESTED: 12:50, POTASSIUM: >9 MMOL/L, SODIUM: 132 MMOL/L, SAMPLE: WHOLE BLOOD. I-STAT, 07/11/2019, 12:56, 3.9 MMOL/L, 141 MMOL/L, SERUM. 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 Information

  MAUDE report 8842655 ↗
• MalfunctionOct 20, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Vitrectomy

  MAUDE report 6966389 ↗
• MalfunctionOct 11, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT E3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HCT AND HGB RESULTS ON A PATIENT ADMITTED FOR COMPLICATIONS ASSOCIATED WITH CROHN'S DISEASE. GI BLEEDING, WEAKNESS/DIZZINESS, DIARRHEA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. I-STAT HCT 43, I-STAT SAMPLE COLLECTED AND RUN IMMEDIATELY ON THE ISTAT AFTER DRAW, I-STAT SAMPLE RESULTED AT 19:55. ISTAT HGB 14.6. SYSMEX HCT 21, SYSMEX SAMPLE COLLECTED AT 19:40, SYSMEX SAMPLE RESULTED AT 1945 SYSMEX HGB 7. 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: Dizziness; Weakness

  MAUDE report 6941673 ↗
• 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 E3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT NA RESULTS ON A PATIENT. NO PATIENT INFORMATION WAS PROVIDED. TESTING PERFORMED ON (B)(6)2017. (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 6941392 ↗
• 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 E3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A PATIENT. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. 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: No Information

  MAUDE report 6931074 ↗
• MalfunctionOct 7, 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 E3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT POTASSIUM (K) RESULT ON A PATIENT. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT, THE PATIENT WAS TREATED BASED ON THE LAB RESULTS. 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: No Information

  MAUDE report 6927013 ↗