Skip to content

i-STAT 03P75-54Recalls & reported problems

Abbott Point Of Care Inc. · i-Stat 1 Wireless Analyzer · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00054749003396), received between Aug 29, 2018 and Aug 29, 2018 — 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

Device problems

  • Electrical /Electronic Property Problem1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionAug 29, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER (B)(4) WOULD NOT ACTIVATE. THE CUSTOMER STATES THE RECHARGEABLE BATTERY WAS REPLACED, PLACED ON THE DOCKING STATION AND WAS HOT TO THE TOUCH WHEN REMOVED FROM THE DOWNLOADER. THE CUSTOMER STATES THERE WAS NO VISIBLE SMOKE BUT IT SMELLED LIKE A COMPONENT BURNED AND WAS HOT TO THE TOUCH. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATES THAT OTHER ANALYZERS ARE WORKING FINE ON THE DOWNLOADER. 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 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

    Patient problems: No Patient Involvement

    MAUDE report 7826112 ↗

Other GLUCOSE OXIDASE, GLUCOSE devices

All GLUCOSE OXIDASE, GLUCOSE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.