i-STAT 03P75-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00054749003792), received between Nov 6, 2019 and Nov 6, 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.

• MalfunctionNov 6, 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) BECAME HOT TO TOUCH. THE ANALYZER WAS PUT IN THE DOWNLOADER WITHOUT ANY BATTERY, FOR TWO DAYS, SINCE IT WAS RECEIVED. THE CUSTOMER HAS NOT USED THE ANALYZER FOR ANY TESTING AND THERE WAS NO IMPACT TO PATIENT CARE. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER 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 NO BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THE INVESTIGATION IS UNDERWAY

  Patient problems: No Patient Involvement

  MAUDE report 9283905 ↗