i-STAT 03P75-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00054749003358), received between Aug 21, 2019 and Aug 21, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(4) YIELDED QUALITY CHECK CODES 29 & 23, BECAME HOT TO THE TOUCH. THE ANALYZER WAS NOT IN A DOCKING STATION AT THE TIME OF THE EVENT. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE PRODUCT WAS REPLACED AT NO CHARGE AND RETURNING 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. 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 8915109 ↗