I-STAT1 ANALYZER, IMMUNO READY
Received Nov 12, 2025 · Event occurred Nov 5, 2025
Report 2245578-2025-00135 · MDR key 23532758
Device
Generic name
I-stat1 Analyzer
Manufacturer
Abbott Point Of CareModel number
NACatalog number
04P75-37
Lot number
NA
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE LAPAROSCOPE EXPERIENCED THAT VISION IS BLURRED WHEN INSERTED INTO THE PATIENT'S CAVITY AND VISIBLE DAMAGE TO THE TUBE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
Additional Manufacturer Narrative
APOC INCIDENT: # (B)(4). THE CUSTOMER REPORTED THAT ANALYZER SN (B)(6) BECOMES HOT WHEN USING A RECHARGEABLE BATTERY WITH A BORN-ON DATE OF 2011-05. THE RECHARGEABLE BATTERY WITH A USED AT THE CUSTOMER SITE WAS DISCARDED AND NOT RETURNED. FAILURE ANALYSIS DID NOT CONFIRM OR REPRODUCE THE CUSTOMER'S COMPLAINT OF HOT TO TOUCH. THE CUSTOMER ALSO REPORTED THAT A QUALITY CHECK CODE 66 WAS DISPLAYED ON THE ANALYZER. THE CAUSE OF QCC 66 WAS DETERMINED TO BE FAILURE OF COMPONENTS U2 AND U51 ON THE ANALYZER'S MAIN BOARD. THE COMPONENTS U2 AND U51 ARE NOT ASSOCIATED WITH HOT TO TOUCH.
Description of Event or Problem
NA.