i-STAT 04P75-01RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00054749003600), received between Feb 9, 2018 and Dec 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED ELECTRONIC BURNING, POSSIBLY BURNT LITHIUM SMELL ON THEIR I-STAT 1 ANALYZER SN (B)(6). CUSTOMER STATES THE ANALYZER GOT VERY HOT AND HAD BURNT GOLDEN CONTACT PADS ON BACK SIDE OF IT WHERE IT WOULD DOCK ONTO THE DOWNLOADER. CUSTOMER STATES THAT ENERGIZER LITHIUM BATTERIES WERE USED. CUSTOMER THREW OUT THE BOX OF ENERGIZER LITHIUM BATTERIES. A NEW LOT WAS ACQUIRED AND RUN WITH NO ISSUES ON OTHER ANALYZERS. CUSTOMER STATES THEY ARE USING RED FUSED BATTERY CARRIERS AND ASKED IF LEAVING THEM DOCKED ON THE DOWNLOADER OVERNIGHT MAY HAVE CAUSED THE OVER-HEATING. APOC TECHNICAL SUPPORT ADVISED THAT RECHARGEABLE BATTERIES ARE RECOMMENDED FOR THE DOWNLOADER RECHARGER. ANALYZER WILL BE REPLACED AT NO CHARGE AND RETURNED FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THERE ARE NO INJURIES ASSOCIATED WITH THE EVENTS. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354821 ↗
• MalfunctionFeb 9, 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 ANALYZER SN (B)(4) THAT YIELDED SUSPECTED DISCREPANT GLUCOSE RESULTS ON MULTIPLE PATIENTS. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CUSTOMER REPORTS THEY RAN CARTRIDGE LOTS H17265B AND H17234 ON A DIFFERENT ANALYZER AND THERE HAVE BEEN NO ISSUES. I-STAT(313271): GLUCOMETER: CHEMISTRY ANALYZER: RESULT: 71, 42, 50. RESULT: 50, 42, 41. RESULT: 79, 52, 34. RESULT: 61, 48, 51. RESULT: 76, 48, 54. 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 Information

  MAUDE report 7260911 ↗