MalfunctionCGL

I-STAT

Received Mar 10, 2023 · Event occurred Dec 8, 2022

Report 16521203 · MDR key 16521203

Device

Generic name

Electrode, Ion Based, Enzymatic, Creatinine

Manufacturer

Abbott Point Of Care Inc.

Model number

03P84-25

Catalog number

03P84-25

Product problems

Defective Component

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DEFECTIVE CARTRIDGES READING ERROR#24 DURING QC EVALUATION. ABBOTT HAS ASKED ME TO RETURN CARTRIDGES SO THEY CAN PERFORM AN INVESTIGATION. RESOLUTION CAN TAKE UP TO 90 DAYS. WE HAVE ORDERED NEW SHIPMENT IN THE MEANTIME.