MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT; ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Model Number 03P84-25

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

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.

• Brand Name: I-STAT
• Type of Device: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road east; princeton NJ 08540
• MDR Report Key: 16521203
• MDR Text Key: 311069629
• Report Number: 16521203
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03P84-25
• Device Catalogue Number: 03P84-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1