I-STAT CG4+ CARTRIDGE
Received Apr 8, 2026 · Event occurred Mar 23, 2026
Report 2245578-2026-00087 · MDR key 24814828
Device
Generic name
Cg4+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P85-25
Lot number
M25317
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
Description of Event or Problem
ON (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT DATE: (B)(6) 2026 TESTED: 19:04, PCO2: 51.2 MMHG, LACTATE: 2.26 MMOL/L SAMPLE: A. METHOD: I-STAT DATE: (B)(6) 2026 TESTED: 19:20 PCO2: 48.1 MMHG LACTATE: 9.88 MMOL/L SAMPLE: B. 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 THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.