i-STAT 03P75-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00054749001408), received between Aug 25, 2017 and Oct 28, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10747995 ↗
• MalfunctionAug 10, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 06/04/2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT ANALYZER SN (B)(4) WAS TOO HOT TO TOUCH AND THERE WAS DAMAGE TO THE CASE. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATED THAT THE ANALYZER WAS DOCKED ON I-STAT DOWNLOADER RECHARGER DRC-79334 AND THEY FOUND THE ANALYZER HOT TO TOUCH WHILE IN THE DOCKING STATION. APOC HAS REPLACED THE ANALYZER, DOWNLOADER RECHARGER DRC-79334, ALOLNG WITH THE RECHARGEABLE BATTERY AT NO CHARGE TO BE RETURNED FOR INVESTIGATION AS A COMPLETE UNIT. 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. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 10386456 ↗
• MalfunctionMay 20, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Patient Involvement

  MAUDE report 10074987 ↗
• MalfunctionAug 25, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6)2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) WAS FEELING "EXTREMELY HOT" AND NOT ACTIVATING . THE CUSTOMER ALSO STATED THAT THERE WAS NO INDICATION OF SMOKE, OR BURNING SMELL. THERE WAS NO IMPACT TO PATIENT CARE OR MANAGEMENT AS PATIENTS WERE TESTED ON OTHER I-STAT ANALYZERS. THE I-STAT WAS OPERATING WITH RECHARGEABLE BATTERIES. 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. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 6819961 ↗
• MalfunctionAug 25, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER (B)(4) WAS FEELING "REALLY HOT" AND NOT ACTIVATING. THE CUSTOMER ALSO STATED THAT THERE WAS NO INDICATION OF SMOKE, OR BURNING SMELL. THERE WAS NO IMPACT TO PATIENT CARE OR MANAGEMENT AS PATIENTS WERE TESTED ON OTHER I-STAT ANALYZERS. THE I-STAT WAS OPERATING WITH RECHARGEABLE BATTERIES. 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. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 6819958 ↗